Trial Outcomes & Findings for Optimizing Functional Recovery of Breast Cancer Survivors (NCT NCT03915548)
NCT ID: NCT03915548
Last Updated: 2024-05-03
Results Overview
The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
303 participants
Primary outcome timeframe
The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Results posted on
2024-05-03
Participant Flow
Recruitment occurred between August 2019 and April 2022. Participants were recruited via Dartmouth College, the University of Alabama at Birmingham (UAB), and via Facebook.
19 participants were enrolled and then excluded from the study before assignment to groups. 2 were excluded due to screen failure and 17 were excluded because they did not complete the baseline assessment.
Participant milestones
| Measure |
The Behavioral Activation/ Problem Solving Intervention
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
140
|
|
Overall Study
Session 1
|
139
|
136
|
|
Overall Study
Session 2
|
138
|
135
|
|
Overall Study
Session 3
|
134
|
132
|
|
Overall Study
Session 4
|
131
|
130
|
|
Overall Study
Session 5
|
128
|
128
|
|
Overall Study
Session 6
|
127
|
126
|
|
Overall Study
Follow-up Data Collection 1 (Week 8)
|
124
|
128
|
|
Overall Study
Session 7
|
126
|
124
|
|
Overall Study
Session 8
|
126
|
119
|
|
Overall Study
Session 9
|
120
|
119
|
|
Overall Study
Follow-up Data Collection 2 (Week 20)
|
123
|
124
|
|
Overall Study
Follow-up Data Collection 3 (Week 44)
|
118
|
113
|
|
Overall Study
COMPLETED
|
118
|
113
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Functional Recovery of Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
56.2 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Employment Status
Employed (FT/PT)
|
75 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Employment Status
Homemaker/Retired
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Employment Status
On Short/Long Term Disability
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Employment Status
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Employment Status
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education Level
Some High school/High school Graduate
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Education Level
Some College (2 year)
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Education Level
Graduate (4 year, Master's, Doctoral)
|
98 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Education Level
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Never Married
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital Status
Married/Living with a partner
|
98 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Marital Status
Separated/Divorced
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
0
|
103 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
1
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
2
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
3
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
4
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of Dependent Children Living at Home
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance Status
Other/None, Self pay
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Insurance Status
Medicaid/Medicare, or other government insurance
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Insurance Status
Private through employer
|
96 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Insurance Status
Missing
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Household Income
Less than $40,000 per year
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Household Income
$40,000 per year or more
|
114 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Household Income
Missing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Rurality
Urban
|
95 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Rurality
Rural
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Rurality
Missing
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cancer Stage
Stage I
|
55 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Cancer Stage
Stage II
|
60 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Cancer Stage
Stage III
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Cancer Treatment
Surgery
|
143 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Cancer Treatment
Radiation
|
118 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Cancer Treatment
Chemotherapy
|
96 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Time Since End of Primary Cancer Treatment
<6 months
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Time Since End of Primary Cancer Treatment
>6 months
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Disability Days
Days Miss Work
|
3 Days
STANDARD_DEVIATION 6 • n=5 Participants
|
2.1 Days
STANDARD_DEVIATION 4.5 • n=7 Participants
|
2.5 Days
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Disability Days
Days in Bed
|
2.8 Days
STANDARD_DEVIATION 5.3 • n=5 Participants
|
4.2 Days
STANDARD_DEVIATION 7.3 • n=7 Participants
|
3.5 Days
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
PROMIS: Satisfaction with Social Roles & Activities
|
45.6 T-score
STANDARD_DEVIATION 6.5 • n=5 Participants
|
45.8 T-score
STANDARD_DEVIATION 6.9 • n=7 Participants
|
45.7 T-score
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
PROMIS: Ability to Participate in Social Roles & Activities
|
43.4 T-score
STANDARD_DEVIATION 5.2 • n=5 Participants
|
43.3 T-score
STANDARD_DEVIATION 5.5 • n=7 Participants
|
43.3 T-score
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Work Limitations Questionnaire scale score
|
34.5 units on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
36.0 units on a scale
STANDARD_DEVIATION 19.3 • n=7 Participants
|
35.3 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Quality of Life, FACT-G
Physical
|
17 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
17 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Quality of Life, FACT-G
Social
|
19.9 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 6.5 • n=7 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Quality of Life, FACT-G
Emotional
|
15.9 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
15.9 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Quality of Life, FACT-G
Functional
|
16.5 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Quality of Life, FACT-G
Overall Score
|
69.3 units on a scale
STANDARD_DEVIATION 16.3 • n=5 Participants
|
68.1 units on a scale
STANDARD_DEVIATION 17.5 • n=7 Participants
|
68.7 units on a scale
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Brief COPE
Active coping
|
6.3 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Brief COPE
Planning
|
6.3 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Brief COPE
Positive reframing
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Goal Adjustment Scale
Disengagement
|
10 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Goal Adjustment Scale
Reengagement
|
21.5 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Hospital Anxiety Depression Scale (HADS)
Anxiety
|
9.4 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Hospital Anxiety Depression Scale (HADS)
Depression
|
6.0 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Work and Social Adjustment Scale (WASA) score
|
16.3 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 7.1 • n=7 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Participation Satisfaction in Social Roles and Activities: PROMIS
Week 0
|
45.75 T-score
Standard Error .43
|
46 T-score
Standard Error .44
|
|
Participation Satisfaction in Social Roles and Activities: PROMIS
Week 20
|
50.47 T-score
Standard Error .47
|
49.81 T-score
Standard Error .47
|
|
Participation Satisfaction in Social Roles and Activities: PROMIS
Week 44
|
50.85 T-score
Standard Error .48
|
51.39 T-score
Standard Error .49
|
|
Participation Satisfaction in Social Roles and Activities: PROMIS
Week 8
|
48.09 T-score
Standard Error .47
|
47.61 T-score
Standard Error .46
|
PRIMARY outcome
Timeframe: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Participation Ability in Social Roles and Activities
Week 0
|
43.55 T-scores
Standard Error .4
|
43.48 T-scores
Standard Error .41
|
|
Participation Ability in Social Roles and Activities
Week 8
|
45.55 T-scores
Standard Error .43
|
44.95 T-scores
Standard Error .43
|
|
Participation Ability in Social Roles and Activities
Week 20
|
47.27 T-scores
Standard Error .43
|
46.44 T-scores
Standard Error .43
|
|
Participation Ability in Social Roles and Activities
Week 44
|
47.43 T-scores
Standard Error .44
|
48.63 T-scores
Standard Error .45
|
PRIMARY outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Productivity
Week 0
|
1.32 days
Standard Error .17
|
1.15 days
Standard Error .15
|
|
Productivity
Week 8
|
1.03 days
Standard Error .14
|
.91 days
Standard Error .12
|
|
Productivity
Week 20
|
1.22 days
Standard Error .16
|
.87 days
Standard Error .12
|
|
Productivity
Week 44
|
.88 days
Standard Error .13
|
.76 days
Standard Error .11
|
PRIMARY outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Work Productivity
Week 0
|
34.7 score on a scale
Standard Error 1.58
|
34.15 score on a scale
Standard Error 1.6
|
|
Work Productivity
Week 8
|
27.87 score on a scale
Standard Error 1.71
|
25.35 score on a scale
Standard Error 1.67
|
|
Work Productivity
Week 20
|
25.13 score on a scale
Standard Error 1.73
|
23.57 score on a scale
Standard Error 1.69
|
|
Work Productivity
Week 44
|
22.79 score on a scale
Standard Error 1.73
|
21.14 score on a scale
Standard Error 1.75
|
SECONDARY outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Overall score: Week 8
|
73.44 score on a scale
Standard Error .93
|
73.36 score on a scale
Standard Error .92
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Overall score: Week 44
|
76.16 score on a scale
Standard Error .95
|
76.23 score on a scale
Standard Error .97
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Physical subscale: Week 20
|
19.78 score on a scale
Standard Error .33
|
20.01 score on a scale
Standard Error .33
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Social subscale: Week 8
|
19.39 score on a scale
Standard Error .33
|
19.69 score on a scale
Standard Error .33
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Social subscale: Week 20
|
20.14 score on a scale
Standard Error .34
|
20.07 score on a scale
Standard Error .34
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Emotional subscale: Week 8
|
17.2 score on a scale
Standard Error .25
|
16.75 score on a scale
Standard Error .25
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Emotional subscale: Week 20
|
17.66 score on a scale
Standard Error .26
|
17.48 score on a scale
Standard Error .25
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Emotional subscale: Week 44
|
17.6 score on a scale
Standard Error .26
|
17.55 score on a scale
Standard Error .26
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Functional subscale: Week 0
|
16.56 score on a scale
Standard Error .31
|
16.59 score on a scale
Standard Error .31
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Functional subscale: Week 8
|
17.78 score on a scale
Standard Error .33
|
18.17 score on a scale
Standard Error .33
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Functional subscale: Week 20
|
18.58 score on a scale
Standard Error .33
|
19.01 score on a scale
Standard Error .33
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Overall score: Week 0
|
69.66 score on a scale
Standard Error .87
|
69.45 score on a scale
Standard Error .89
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Overall score: Week 20
|
76.25 score on a scale
Standard Error .93
|
76.49 score on a scale
Standard Error .93
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Physical subscale: Week 0
|
17.21 score on a scale
Standard Error .31
|
17.31 score on a scale
Standard Error .32
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Physical subscale: Week 8
|
18.96 score on a scale
Standard Error .33
|
18.82 score on a scale
Standard Error .33
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Physical subscale: Week 44
|
19.59 score on a scale
Standard Error .34
|
19.55 score on a scale
Standard Error .35
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Social subscale: Week 0
|
19.79 score on a scale
Standard Error .31
|
19.64 score on a scale
Standard Error .32
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Social subscale: Week 44
|
19.76 score on a scale
Standard Error .34
|
19.97 score on a scale
Standard Error .35
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Emotional subscale: Week 0
|
15.99 score on a scale
Standard Error .24
|
16.01 score on a scale
Standard Error .24
|
|
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Functional subscale: Week 44
|
19.11 score on a scale
Standard Error .33
|
19.28 score on a scale
Standard Error .34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Coping
Positive reframing: Week 0
|
6.35 score on a scale
Standard Error .11
|
6.48 score on a scale
Standard Error .11
|
|
Coping
Positive reframing: Week 8
|
6.6 score on a scale
Standard Error .12
|
6.57 score on a scale
Standard Error .12
|
|
Coping
Active coping: Week 0
|
6.35 score on a scale
Standard Error .11
|
6.48 score on a scale
Standard Error .11
|
|
Coping
Active coping: Week 8
|
6.68 score on a scale
Standard Error .11
|
6.58 score on a scale
Standard Error .11
|
|
Coping
Active coping: Week 20
|
6.68 score on a scale
Standard Error .12
|
6.58 score on a scale
Standard Error .12
|
|
Coping
Active coping: Week 44
|
6.55 score on a scale
Standard Error .12
|
6.35 score on a scale
Standard Error .12
|
|
Coping
Planning: Week 0
|
6.33 score on a scale
Standard Error .12
|
6.54 score on a scale
Standard Error .12
|
|
Coping
Planning: Week 8
|
6.8 score on a scale
Standard Error .13
|
6.58 score on a scale
Standard Error .12
|
|
Coping
Planning: Week 20
|
6.95 score on a scale
Standard Error .13
|
6.53 score on a scale
Standard Error .13
|
|
Coping
Planning: Week 44
|
6.52 score on a scale
Standard Error .13
|
6.5 score on a scale
Standard Error .13
|
|
Coping
Positive reframing: Week 20
|
6.58 score on a scale
Standard Error .12
|
6.56 score on a scale
Standard Error .12
|
|
Coping
Positive reframing: Week 44
|
6.4 score on a scale
Standard Error .12
|
6.48 score on a scale
Standard Error .12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Goal Adjustment
Disengagement: Week 0
|
10.3 score on a scale
Standard Error .21
|
10.6 score on a scale
Standard Error .22
|
|
Goal Adjustment
Disengagement: Week 8
|
11.3 score on a scale
Standard Error .23
|
10.67 score on a scale
Standard Error .22
|
|
Goal Adjustment
Disengagement: Week 20
|
11.29 score on a scale
Standard Error .23
|
10.43 score on a scale
Standard Error .23
|
|
Goal Adjustment
Disengagement: Week 44
|
11.47 score on a scale
Standard Error .23
|
10.39 score on a scale
Standard Error .24
|
|
Goal Adjustment
Reengagement: Week 0
|
21.26 score on a scale
Standard Error .27
|
21.14 score on a scale
Standard Error .28
|
|
Goal Adjustment
Reengagement: Week 8
|
21.4 score on a scale
Standard Error .29
|
21.81 score on a scale
Standard Error .29
|
|
Goal Adjustment
Reengagement: Week 20
|
22.03 score on a scale
Standard Error .3
|
22.01 score on a scale
Standard Error .29
|
|
Goal Adjustment
Reengagement: Week 44
|
21.5 score on a scale
Standard Error .3
|
22.03 score on a scale
Standard Error .31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=144 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=140 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Distress
Anxiety: Week 0
|
9.08 score on a scale
Standard Error .22
|
8.98 score on a scale
Standard Error .23
|
|
Distress
Anxiety: Week 8
|
7.79 score on a scale
Standard Error .24
|
7.68 score on a scale
Standard Error .24
|
|
Distress
Depression: Week 20
|
4.87 score on a scale
Standard Error .22
|
5.18 score on a scale
Standard Error .22
|
|
Distress
Depression: Week 44
|
5.2 score on a scale
Standard Error .23
|
4.89 score on a scale
Standard Error .23
|
|
Distress
Anxiety: Week 20
|
7.44 score on a scale
Standard Error .24
|
7.49 score on a scale
Standard Error .24
|
|
Distress
Anxiety: Week 44
|
7.42 score on a scale
Standard Error .24
|
7.19 score on a scale
Standard Error .25
|
|
Distress
Depression: Week 0
|
6.13 score on a scale
Standard Error .21
|
6.28 score on a scale
Standard Error .21
|
|
Distress
Depression: Week 8
|
5.17 score on a scale
Standard Error .22
|
5.33 score on a scale
Standard Error .22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast.Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance.
Outcome measures
| Measure |
The Behavioral Activation/ Problem Solving Intervention
n=139 Participants
BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
|
Attention Control Condition
n=136 Participants
Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
|
|---|---|---|
|
Occupational Performance
Importance: Session 1 (baseline)
|
8.66 score on a scale
Standard Error .08
|
8.87 score on a scale
Standard Error .08
|
|
Occupational Performance
Importance: Session 9 (approximately week 20)
|
8.78 score on a scale
Standard Error .09
|
8.75 score on a scale
Standard Error .09
|
|
Occupational Performance
Performance: Session 9 (approximately week 20)
|
6.99 score on a scale
Standard Error .13
|
6.3 score on a scale
Standard Error .13
|
|
Occupational Performance
Satisfaction: Session 1 (baseline)
|
3.74 score on a scale
Standard Error .14
|
3.93 score on a scale
Standard Error .14
|
|
Occupational Performance
Satisfaction: Session 9 (approximately week 20)
|
7.15 score on a scale
Standard Error .15
|
6.08 score on a scale
Standard Error .15
|
|
Occupational Performance
Performance: Session 1 (baseline)
|
4.13 score on a scale
Standard Error .12
|
4.29 score on a scale
Standard Error .12
|
Adverse Events
The Behavioral Activation/ Problem Solving Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place