Trial Outcomes & Findings for A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers (NCT NCT03016403)
NCT ID: NCT03016403
Last Updated: 2021-03-19
Results Overview
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
535 participants
Primary outcome timeframe
6-months
Results posted on
2021-03-19
Participant Flow
Both patients and caregivers were recruited for this study. Primary outcomes data were focused on patients. Caregiver data were included as secondary analyses.
Participant milestones
| Measure |
Patients in Enhanced Usual Care
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
Patients who were randomized to the Stepped Care Intervention
|
Caregivers in Enhanced Usual Care
Caregivers who were randomized into Enhanced Usual Care
|
Caregivers in Stepped Care Intervention
Caregivers who were randomized to the Stepped Care Intervention
|
|---|---|---|---|---|
|
Baseline
STARTED
|
139
|
147
|
118
|
131
|
|
Baseline
COMPLETED
|
123
|
120
|
107
|
97
|
|
Baseline
NOT COMPLETED
|
16
|
27
|
11
|
34
|
|
6-week Follow-up
STARTED
|
123
|
120
|
107
|
97
|
|
6-week Follow-up
COMPLETED
|
120
|
107
|
103
|
88
|
|
6-week Follow-up
NOT COMPLETED
|
3
|
13
|
4
|
9
|
|
3-month Follow-up and 6-month Follow-up
STARTED
|
120
|
107
|
103
|
88
|
|
3-month Follow-up and 6-month Follow-up
COMPLETED
|
108
|
96
|
95
|
81
|
|
3-month Follow-up and 6-month Follow-up
NOT COMPLETED
|
12
|
11
|
8
|
7
|
Reasons for withdrawal
| Measure |
Patients in Enhanced Usual Care
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
Patients who were randomized to the Stepped Care Intervention
|
Caregivers in Enhanced Usual Care
Caregivers who were randomized into Enhanced Usual Care
|
Caregivers in Stepped Care Intervention
Caregivers who were randomized to the Stepped Care Intervention
|
|---|---|---|---|---|
|
Baseline
Death
|
5
|
8
|
1
|
0
|
|
Baseline
Withdrawal by Subject
|
2
|
8
|
4
|
10
|
|
Baseline
Lost to Follow-up
|
9
|
11
|
6
|
24
|
|
6-week Follow-up
Death
|
1
|
4
|
0
|
0
|
|
6-week Follow-up
Lost to Follow-up
|
2
|
7
|
4
|
8
|
|
6-week Follow-up
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
|
3-month Follow-up and 6-month Follow-up
Death
|
6
|
4
|
0
|
0
|
|
3-month Follow-up and 6-month Follow-up
Lost to Follow-up
|
6
|
7
|
8
|
6
|
|
3-month Follow-up and 6-month Follow-up
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Diagnosis data were not collected from caregivers.
Baseline characteristics by cohort
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
Caregivers in Enhanced Usual Care
n=118 Participants
Caregivers who were randomized to Enhanced Usual Care
|
Caregivers in Stepped Care Intervention
n=131 Participants
Caregivers who were randomized to the Stepped Care Intervention
|
Total
n=535 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Under 18
|
0 Participants
n=139 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=535 Participants
|
|
Age, Customized
18 to 65
|
65 Participants
n=139 Participants
|
69 Participants
n=147 Participants
|
64 Participants
n=118 Participants
|
69 Participants
n=131 Participants
|
267 Participants
n=535 Participants
|
|
Age, Customized
Above 65
|
74 Participants
n=139 Participants
|
78 Participants
n=147 Participants
|
33 Participants
n=118 Participants
|
36 Participants
n=131 Participants
|
221 Participants
n=535 Participants
|
|
Age, Customized
Unknown or Not Report
|
0 Participants
n=139 Participants
|
0 Participants
n=147 Participants
|
21 Participants
n=118 Participants
|
26 Participants
n=131 Participants
|
47 Participants
n=535 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=139 Participants
|
65 Participants
n=147 Participants
|
92 Participants
n=118 Participants
|
99 Participants
n=131 Participants
|
310 Participants
n=535 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=139 Participants
|
82 Participants
n=147 Participants
|
26 Participants
n=118 Participants
|
32 Participants
n=131 Participants
|
225 Participants
n=535 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=139 Participants
|
34 Participants
n=147 Participants
|
28 Participants
n=118 Participants
|
37 Participants
n=131 Participants
|
126 Participants
n=535 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=139 Participants
|
113 Participants
n=147 Participants
|
89 Participants
n=118 Participants
|
94 Participants
n=131 Participants
|
408 Participants
n=535 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=139 Participants
|
0 Participants
n=147 Participants
|
1 Participants
n=118 Participants
|
0 Participants
n=131 Participants
|
1 Participants
n=535 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=139 Participants
|
3 Participants
n=147 Participants
|
1 Participants
n=118 Participants
|
3 Participants
n=131 Participants
|
8 Participants
n=535 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=139 Participants
|
1 Participants
n=147 Participants
|
6 Participants
n=118 Participants
|
5 Participants
n=131 Participants
|
13 Participants
n=535 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=139 Participants
|
0 Participants
n=147 Participants
|
3 Participants
n=118 Participants
|
0 Participants
n=131 Participants
|
4 Participants
n=535 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=139 Participants
|
9 Participants
n=147 Participants
|
3 Participants
n=118 Participants
|
7 Participants
n=131 Participants
|
25 Participants
n=535 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=139 Participants
|
122 Participants
n=147 Participants
|
99 Participants
n=118 Participants
|
107 Participants
n=131 Participants
|
451 Participants
n=535 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=139 Participants
|
1 Participants
n=147 Participants
|
2 Participants
n=118 Participants
|
2 Participants
n=131 Participants
|
7 Participants
n=535 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=139 Participants
|
11 Participants
n=147 Participants
|
4 Participants
n=118 Participants
|
7 Participants
n=131 Participants
|
27 Participants
n=535 Participants
|
|
Region of Enrollment
United States
|
139 participants
n=139 Participants
|
147 participants
n=147 Participants
|
118 participants
n=118 Participants
|
131 participants
n=131 Participants
|
286 participants
n=535 Participants
|
|
Language Preference
English
|
133 Participants
n=139 Participants
|
132 Participants
n=147 Participants
|
111 Participants
n=118 Participants
|
118 Participants
n=131 Participants
|
494 Participants
n=535 Participants
|
|
Language Preference
Spanish
|
6 Participants
n=139 Participants
|
15 Participants
n=147 Participants
|
7 Participants
n=118 Participants
|
13 Participants
n=131 Participants
|
41 Participants
n=535 Participants
|
|
Diagnosis
Head and neck cancer
|
60 Participants
n=139 Participants • Diagnosis data were not collected from caregivers.
|
60 Participants
n=147 Participants • Diagnosis data were not collected from caregivers.
|
0 Participants
Diagnosis data were not collected from caregivers.
|
0 Participants
Diagnosis data were not collected from caregivers.
|
120 Participants
n=286 Participants • Diagnosis data were not collected from caregivers.
|
|
Diagnosis
Lung cancer
|
79 Participants
n=139 Participants • Diagnosis data were not collected from caregivers.
|
87 Participants
n=147 Participants • Diagnosis data were not collected from caregivers.
|
0 Participants
Diagnosis data were not collected from caregivers.
|
0 Participants
Diagnosis data were not collected from caregivers.
|
166 Participants
n=286 Participants • Diagnosis data were not collected from caregivers.
|
|
Cancer Stage
Stage 0, I, & II
|
65 Participants
n=139 Participants • No cancer stage was collected from the caregivers.
|
67 Participants
n=147 Participants • No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
132 Participants
n=286 Participants • No cancer stage was collected from the caregivers.
|
|
Cancer Stage
Stage III & IV
|
73 Participants
n=139 Participants • No cancer stage was collected from the caregivers.
|
78 Participants
n=147 Participants • No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
151 Participants
n=286 Participants • No cancer stage was collected from the caregivers.
|
|
Cancer Stage
Unknown or Not Reported
|
1 Participants
n=139 Participants • No cancer stage was collected from the caregivers.
|
2 Participants
n=147 Participants • No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
0 Participants
No cancer stage was collected from the caregivers.
|
3 Participants
n=286 Participants • No cancer stage was collected from the caregivers.
|
|
Step at Baseline
Step 1 & 2
|
106 Participants
n=139 Participants
|
114 Participants
n=147 Participants
|
89 Participants
n=118 Participants
|
106 Participants
n=131 Participants
|
415 Participants
n=535 Participants
|
|
Step at Baseline
Step 3 & 4
|
33 Participants
n=139 Participants
|
32 Participants
n=147 Participants
|
29 Participants
n=118 Participants
|
25 Participants
n=131 Participants
|
119 Participants
n=535 Participants
|
|
Step at Baseline
Unknown or Not Reported
|
0 Participants
n=139 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=118 Participants
|
0 Participants
n=131 Participants
|
1 Participants
n=535 Participants
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: Intention to treat population- all participants who were randomized were included in this analysis. The reported means correspond to the observed means at 6 months.
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Symptoms of Depression-Patients
|
15.3 score on a scale
Standard Deviation 7.0
|
13.2 score on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: Intention to treat population.
Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Symptoms of Anxiety-Patients
|
16.0 score on a scale
Standard Deviation 7.0
|
13.9 score on a scale
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: Intention to treat population.
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Change in Coping-Patients
|
190 score on a scale
Standard Deviation 55
|
207 score on a scale
Standard Deviation 54
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Intention to treat population.
Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=118 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=131 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Change in Coping-Caregivers
|
192 score on a scale
Standard Deviation 52
|
211 score on a scale
Standard Deviation 50
|
SECONDARY outcome
Timeframe: 6-monthsPROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=118 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=131 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Symptoms of Anxiety-Caregivers
|
17 score on a scale
Standard Deviation 7
|
14 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 6-monthsPROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=118 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=131 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Symptoms of Depression-Caregivers
|
15.0 score on a scale
Standard Deviation 6.9
|
13.2 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Intention to treat population.
FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Health-Related Quality of Life-Patients
|
73 score on a scale
Standard Deviation 19
|
80 score on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: intention to treat population
Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=139 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Perceived Stress-Patients
|
14 score on a scale
Standard Deviation 7
|
13 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 6-monthsPerceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=118 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=131 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Perceived Stress-Caregivers
|
15 score on a scale
Standard Deviation 7
|
11 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 6-monthsZarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Outcome measures
| Measure |
Patients in Enhanced Usual Care
n=118 Participants
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=131 Participants
Patients who were randomized to the Stepped Care Intervention
|
|---|---|---|
|
Caregiving Burden-Caregivers
|
13 score on a scale
Standard Deviation 9
|
9 score on a scale
Standard Deviation 8
|
Adverse Events
Patients in Enhanced Usual Care
Serious events: 13 serious events
Other events: 0 other events
Deaths: 13 deaths
Patients in Stepped Care Intervention
Serious events: 19 serious events
Other events: 0 other events
Deaths: 18 deaths
Caregivers in Enhanced Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Caregivers in Stepped Care Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients in Enhanced Usual Care
n=139 participants at risk
Patients who were randomized to Enhanced Usual Care
|
Patients in Stepped Care Intervention
n=147 participants at risk
Patients who were randomized to the Stepped Care Intervention
|
Caregivers in Enhanced Usual Care
n=118 participants at risk
Caregivers who were randomized to Enhanced Usual Care
|
Caregivers in Stepped Care Intervention
n=131 participants at risk
Caregivers who were randomized to the Stepped Care Intervention
|
|---|---|---|---|---|
|
General disorders
Death
|
9.4%
13/139 • Number of events 13 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
12.2%
18/147 • Number of events 18 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
0.85%
1/118 • Number of events 1 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
0.00%
0/131 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure with hypoxia
|
0.00%
0/139 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
0.68%
1/147 • Number of events 1 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
0.00%
0/118 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
0.00%
0/131 • Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.
|
Other adverse events
Adverse event data not reported
Additional Information
Evelinn Borrayo, Associate Director
Latino Research and Policy Center, University of Colorado Denver
Phone: 303-724-0884
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place