Trial Outcomes & Findings for Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers (NCT NCT04010227)
NCT ID: NCT04010227
Last Updated: 2022-12-22
Results Overview
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
2 weeks and 3 months post-intervention
Results posted on
2022-12-22
Participant Flow
2 patients and 2 caregivers were excluded from the study before assignment to groups. Here is a list of the reasons: Patient death (1) Caregiver withdrew because patient died (1) Patient lost to follow-up (1) Caregiver withdrew because patient was lost to follow-up (1)
Participant milestones
| Measure |
Acceptance and Commitment Therapy
Patients and caregivers in the Acceptance and Commitment Therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Patients Started
|
20
|
20
|
|
Overall Study
Caregivers Started
|
20
|
20
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
Acceptance and Commitment Therapy
Patients and caregivers in the Acceptance and Commitment Therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Medical Reasons
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Caregiver withdrawn because patient was withdrawn for any reason
|
5
|
5
|
Baseline Characteristics
Data are specific to patients.
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy
n=40 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=40 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Chemoradiation
No-chemoradiation not received for gastrointestinal cancer
|
15 Participants
n=20 Participants • Data are specific to patients.
|
16 Participants
n=20 Participants • Data are specific to patients.
|
31 Participants
n=40 Participants • Data are specific to patients.
|
|
Surgery to remove primary tumor
Yes-surgery received to remove primary tumor
|
12 Participants
n=20 Participants • Data are specific to patients.
|
11 Participants
n=20 Participants • Data are specific to patients.
|
23 Participants
n=40 Participants • Data are specific to patients.
|
|
Age, Continuous
Patient age
|
59.25 years
STANDARD_DEVIATION 9.96 • n=20 Participants • Age data are presented separately for patients and caregivers.
|
57.85 years
STANDARD_DEVIATION 15.71 • n=20 Participants • Age data are presented separately for patients and caregivers.
|
58.55 years
STANDARD_DEVIATION 13.00 • n=40 Participants • Age data are presented separately for patients and caregivers.
|
|
Age, Continuous
Caregiver age
|
55.55 years
STANDARD_DEVIATION 14.87 • n=20 Participants • Age data are presented separately for patients and caregivers.
|
48.60 years
STANDARD_DEVIATION 15.80 • n=20 Participants • Age data are presented separately for patients and caregivers.
|
52.08 years
STANDARD_DEVIATION 15.55 • n=40 Participants • Age data are presented separately for patients and caregivers.
|
|
Sex: Female, Male
Patient age · Female
|
10 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
8 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
18 Participants
n=40 Participants • Sex data are presented separately for patients and caregivers.
|
|
Sex: Female, Male
Patient age · Male
|
10 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
12 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
22 Participants
n=40 Participants • Sex data are presented separately for patients and caregivers.
|
|
Sex: Female, Male
Caregiver age · Female
|
3 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
7 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
10 Participants
n=40 Participants • Sex data are presented separately for patients and caregivers.
|
|
Sex: Female, Male
Caregiver age · Male
|
17 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
13 Participants
n=20 Participants • Sex data are presented separately for patients and caregivers.
|
30 Participants
n=40 Participants • Sex data are presented separately for patients and caregivers.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Patient race · American Indian or Alaska Native
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · Asian
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · Black or African American
|
1 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
1 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
2 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · White
|
19 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
19 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
38 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · More than one race
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Patient race · Unknown or Not Reported
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · American Indian or Alaska Native
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · Asian
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · Black or African American
|
2 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
1 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
3 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · White
|
18 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
19 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
37 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · More than one race
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Race (NIH/OMB)
Caregiver race · Unknown or Not Reported
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Racial data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Racial data are presented separately for patients and caregivers.
|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
|
4.25 units on a scale
STANDARD_DEVIATION 1.86 • n=20 Participants • This outcome was only collected on patients.
|
3.58 units on a scale
STANDARD_DEVIATION 1.92 • n=20 Participants • This outcome was only collected on patients.
|
3.91 units on a scale
STANDARD_DEVIATION 1.90 • n=40 Participants • This outcome was only collected on patients.
|
|
Short-Form of Zarit Burden Interview
|
15.85 units on a scale
STANDARD_DEVIATION 3.82 • n=20 Participants • This primary outcome measure was only collected on caregivers.
|
18.45 units on a scale
STANDARD_DEVIATION 8.52 • n=20 Participants • This primary outcome measure was only collected on caregivers.
|
17.15 units on a scale
STANDARD_DEVIATION 6.65 • n=40 Participants • This primary outcome measure was only collected on caregivers.
|
|
Education
Patient education
|
15.48 years
STANDARD_DEVIATION 2.66 • n=20 Participants • Education data are presented separately for patients and caregivers.
|
14.70 years
STANDARD_DEVIATION 2.45 • n=20 Participants • Education data are presented separately for patients and caregivers.
|
15.09 years
STANDARD_DEVIATION 2.56 • n=40 Participants • Education data are presented separately for patients and caregivers.
|
|
Education
Caregiver education
|
15.23 years
STANDARD_DEVIATION 2.67 • n=20 Participants • Education data are presented separately for patients and caregivers.
|
15.45 years
STANDARD_DEVIATION 2.61 • n=20 Participants • Education data are presented separately for patients and caregivers.
|
15.34 years
STANDARD_DEVIATION 2.61 • n=40 Participants • Education data are presented separately for patients and caregivers.
|
|
Household income
Patient income · $0-$50,999
|
5 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
7 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
12 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Patient income · $51,000-$99,999
|
5 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
3 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
8 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Patient income · $100,000 or more
|
10 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
9 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
19 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Patient income · Missing data
|
0 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
1 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
1 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Caregiver income · $0-$50,999
|
5 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
6 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
11 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Caregiver income · $51,000-$99,999
|
9 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
5 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
14 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Caregiver income · $100,000 or more
|
6 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
9 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
15 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Household income
Caregiver income · Missing data
|
0 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
0 Participants
n=20 Participants • Income data are presented separately for patients and caregivers.
|
0 Participants
n=40 Participants • Income data are presented separately for patients and caregivers.
|
|
Caregiver's relationship to the patient
Spouse or partner
|
12 Participants
n=20 Participants • Data are specific to caregivers.
|
13 Participants
n=20 Participants • Data are specific to caregivers.
|
25 Participants
n=40 Participants • Data are specific to caregivers.
|
|
Caregiver's relationship to the patient
Other family member
|
8 Participants
n=20 Participants • Data are specific to caregivers.
|
7 Participants
n=20 Participants • Data are specific to caregivers.
|
15 Participants
n=40 Participants • Data are specific to caregivers.
|
|
Caregiver lives with the patient
Yes, caregiver lives with the patient.
|
15 Participants
n=20 Participants • Data are specific to caregivers.
|
15 Participants
n=20 Participants • Data are specific to caregivers.
|
30 Participants
n=40 Participants • Data are specific to caregivers.
|
|
Caregiver lives with the patient
No, caregiver does not live with the patient.
|
5 Participants
n=20 Participants • Data are specific to caregivers.
|
5 Participants
n=20 Participants • Data are specific to caregivers.
|
10 Participants
n=40 Participants • Data are specific to caregivers.
|
|
Type of gastrointestinal cancer
Colorectal cancer
|
10 Participants
n=20 Participants • Data are specific to patients.
|
6 Participants
n=20 Participants • Data are specific to patients.
|
16 Participants
n=40 Participants • Data are specific to patients.
|
|
Type of gastrointestinal cancer
Pancreatic cancer
|
3 Participants
n=20 Participants • Data are specific to patients.
|
7 Participants
n=20 Participants • Data are specific to patients.
|
10 Participants
n=40 Participants • Data are specific to patients.
|
|
Type of gastrointestinal cancer
Other gastrointestinal cancer
|
7 Participants
n=20 Participants • Data are specific to patients.
|
7 Participants
n=20 Participants • Data are specific to patients.
|
14 Participants
n=40 Participants • Data are specific to patients.
|
|
Time since gastrointestinal cancer diagnosis
|
2.40 years
STANDARD_DEVIATION 2.36 • n=20 Participants • Data are specific to patients.
|
1.67 years
STANDARD_DEVIATION 3.30 • n=20 Participants • Data are specific to patients.
|
2.04 years
STANDARD_DEVIATION 2.85 • n=40 Participants • Data are specific to patients.
|
|
Chemotherapy
Yes-chemotherapy received for gastrointestinal cancer
|
15 Participants
n=20 Participants • Data are specific to patients.
|
17 Participants
n=20 Participants • Data are specific to patients.
|
32 Participants
n=40 Participants • Data are specific to patients.
|
|
Chemotherapy
No-chemotherapy not received for gastrointestinal cancer
|
5 Participants
n=20 Participants • Data are specific to patients.
|
3 Participants
n=20 Participants • Data are specific to patients.
|
8 Participants
n=40 Participants • Data are specific to patients.
|
|
Radiation
Yes-radiation received for gastrointestinal cancer
|
2 Participants
n=20 Participants • Data are specific to patients.
|
6 Participants
n=20 Participants • Data are specific to patients.
|
8 Participants
n=40 Participants • Data are specific to patients.
|
|
Radiation
No-radiation not received for gastrointestinal cancer
|
18 Participants
n=20 Participants • Data are specific to patients.
|
14 Participants
n=20 Participants • Data are specific to patients.
|
32 Participants
n=40 Participants • Data are specific to patients.
|
|
Chemoradiation
Yes-chemoradiation received for gastrointestinal cancer
|
5 Participants
n=20 Participants • Data are specific to patients.
|
4 Participants
n=20 Participants • Data are specific to patients.
|
9 Participants
n=40 Participants • Data are specific to patients.
|
|
Surgery to remove primary tumor
No-surgery not received to remove primary tumor
|
8 Participants
n=20 Participants • Data are specific to patients.
|
9 Participants
n=20 Participants • Data are specific to patients.
|
17 Participants
n=40 Participants • Data are specific to patients.
|
|
Surgery to remove metastases
Yes-received surgery to remove metastases
|
7 Participants
n=20 Participants • Data are specific to patients.
|
4 Participants
n=20 Participants • Data are specific to patients.
|
11 Participants
n=40 Participants • Data are specific to patients.
|
|
Surgery to remove metastases
No--did not receive surgery to remove metastases
|
13 Participants
n=20 Participants • Data are specific to patients.
|
16 Participants
n=20 Participants • Data are specific to patients.
|
29 Participants
n=40 Participants • Data are specific to patients.
|
|
Targeted Therapy
Yes, received targeted therapy for gastrointestinal cancer
|
9 Participants
n=20 Participants • Data are specific to patients.
|
5 Participants
n=20 Participants • Data are specific to patients.
|
14 Participants
n=40 Participants • Data are specific to patients.
|
|
Targeted Therapy
No, did not receive targeted therapy for gastrointestinal cancer
|
11 Participants
n=20 Participants • Data are specific to patients.
|
15 Participants
n=20 Participants • Data are specific to patients.
|
26 Participants
n=40 Participants • Data are specific to patients.
|
PRIMARY outcome
Timeframe: 2 weeks and 3 months post-interventionSeven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=20 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
Patient fatigue interference at 2 weeks post-intervention
|
3.93 units on a scale
Standard Deviation 2.17
|
3.47 units on a scale
Standard Deviation 2.54
|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
Patient fatigue interference at 3 months post-intervention
|
4.27 units on a scale
Standard Deviation 1.66
|
4.26 units on a scale
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: 2 weeks and 3 months post-interventionTwelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=20 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Short-form of Zarit Burden Interview
Caregiver burden at 2 weeks post-intervention
|
13.92 units on a scale
Standard Deviation 3.86
|
16.37 units on a scale
Standard Deviation 7.10
|
|
Short-form of Zarit Burden Interview
Caregiver burden at 3 months post-intervention
|
15.32 units on a scale
Standard Deviation 4.59
|
18.17 units on a scale
Standard Deviation 8.36
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionThis 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=20 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
Patient sleep-related impairment at 2 weeks post-intervention
|
57.37 T-score
Standard Deviation 4.03
|
52.99 T-score
Standard Deviation 8.38
|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
Patient sleep-related impairment at 3 months post-intervention
|
56.91 T-score
Standard Deviation 5.22
|
53.86 T-score
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionPopulation: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=40 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=40 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
PROMIS Ability to Participate in Social Roles and Activities
Patient ability to participate in social roles and activities at 2 weeks post-intervention
|
45.02 T-score
Standard Deviation 6.60
|
42.42 T-score
Standard Deviation 7.26
|
|
PROMIS Ability to Participate in Social Roles and Activities
Patient ability to participate in social roles and activities at 3 months post-intervention
|
45.58 T-score
Standard Deviation 6.92
|
46.14 T-score
Standard Deviation 5.01
|
|
PROMIS Ability to Participate in Social Roles and Activities
Caregiver ability to participate in social roles and activities at 2 weeks post-intervention
|
42.56 T-score
Standard Deviation 4.66
|
40.40 T-score
Standard Deviation 7.05
|
|
PROMIS Ability to Participate in Social Roles and Activities
Caregiver ability to participate in social roles and activities at 3 months post-intervention
|
40.34 T-score
Standard Deviation 2.62
|
41.04 T-score
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionPopulation: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=40 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=40 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Acceptance and Action Questionnaire-II
Caregiver psychological inflexibility at 2 weeks post-intervention
|
17.77 units on a scale
Standard Deviation 6.45
|
17.45 units on a scale
Standard Deviation 8.22
|
|
Acceptance and Action Questionnaire-II
Patient psychological inflexibility at 2 weeks post-intervention
|
13.82 units on a scale
Standard Deviation 4.98
|
14.52 units on a scale
Standard Deviation 6.45
|
|
Acceptance and Action Questionnaire-II
Patient psychological inflexibility at 3 months post-intervention
|
13.85 units on a scale
Standard Deviation 6.04
|
15.97 units on a scale
Standard Deviation 5.61
|
|
Acceptance and Action Questionnaire-II
Caregiver psychological inflexibility at 3 months post-intervention
|
17.58 units on a scale
Standard Deviation 6.21
|
17.79 units on a scale
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionThis 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=20 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
McGill Quality of Life Questionnaire-Revised
Patient physical quality of life at 3 months post-intervention
|
13.48 units on a scale
Standard Deviation 5.40
|
14.80 units on a scale
Standard Deviation 6.33
|
|
McGill Quality of Life Questionnaire-Revised
Patient psychological quality of life at 2 weeks post-intervention
|
28.58 units on a scale
Standard Deviation 8.31
|
29.98 units on a scale
Standard Deviation 5.99
|
|
McGill Quality of Life Questionnaire-Revised
Patient psychological quality of life at 3 months post-intervention
|
28.66 units on a scale
Standard Deviation 8.36
|
26.09 units on a scale
Standard Deviation 8.27
|
|
McGill Quality of Life Questionnaire-Revised
Patient existential quality of life at 3 months post-intervention
|
28.25 units on a scale
Standard Deviation 4.57
|
27.15 units on a scale
Standard Deviation 4.83
|
|
McGill Quality of Life Questionnaire-Revised
Patient physical quality of life at 2 weeks post-intervention
|
17.30 units on a scale
Standard Deviation 6.34
|
16.89 units on a scale
Standard Deviation 6.20
|
|
McGill Quality of Life Questionnaire-Revised
Patient existential quality of life at 2 weeks post-intervention
|
28.18 units on a scale
Standard Deviation 5.35
|
28.15 units on a scale
Standard Deviation 5.06
|
|
McGill Quality of Life Questionnaire-Revised
Patient social quality of life at 2 weeks post-intervention
|
24.59 units on a scale
Standard Deviation 5.18
|
24.80 units on a scale
Standard Deviation 5.32
|
|
McGill Quality of Life Questionnaire-Revised
Patient social quality of life at 3 months post-intervention
|
25.28 units on a scale
Standard Deviation 4.30
|
25.64 units on a scale
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionThis 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=20 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
PROMIS Global Health
Caregiver psychological quality of life at 2 weeks post-intervention
|
45.01 T-score
Standard Deviation 5.11
|
43.48 T-score
Standard Deviation 7.48
|
|
PROMIS Global Health
Caregiver physical quality of life at 2 weeks post-intervention
|
46.11 T-score
Standard Deviation 6.02
|
45.34 T-score
Standard Deviation 5.24
|
|
PROMIS Global Health
Caregiver physical quality of life at 3 months post-intervention
|
45.58 T-score
Standard Deviation 4.42
|
44.68 T-score
Standard Deviation 3.33
|
|
PROMIS Global Health
Caregiver psychological quality of life at 3 months post-intervention
|
43.99 T-score
Standard Deviation 4.50
|
43.30 T-score
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: 2 weeks and 3 months post-interventionPopulation: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=40 Participants
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=40 Participants
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
|---|---|---|
|
Value Progress Subscale of the Valuing Questionnaire.
Patient values progress at 2 weeks post-intervention
|
21.71 units on a scale
Standard Deviation 3.49
|
21.30 units on a scale
Standard Deviation 5.29
|
|
Value Progress Subscale of the Valuing Questionnaire.
Caregiver values progress at 3 months post-intervention
|
22.97 units on a scale
Standard Deviation 2.62
|
22.44 units on a scale
Standard Deviation 3.05
|
|
Value Progress Subscale of the Valuing Questionnaire.
Patient values progress at 3 months post-intervention
|
22.71 units on a scale
Standard Deviation 3.26
|
21.66 units on a scale
Standard Deviation 5.09
|
|
Value Progress Subscale of the Valuing Questionnaire.
Caregiver values progress at 2 weeks post-intervention
|
23.05 units on a scale
Standard Deviation 5.39
|
21.14 units on a scale
Standard Deviation 4.33
|
Adverse Events
Acceptance and Commitment Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Education/Support
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Before Randomization
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Acceptance and Commitment Therapy
n=20 participants at risk
Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
|
Education/Support
n=20 participants at risk
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
|
Before Randomization
n=22 participants at risk
All-cause mortality and adverse events prior to randomization to a study arm
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Deaths
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected on each participant from the point of baseline until 21 weeks post-baseline.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected on each participant from the point of baseline until 21 weeks post-baseline.
|
4.5%
1/22 • Number of events 1 • Adverse event data were collected on each participant from the point of baseline until 21 weeks post-baseline.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place