Trial Outcomes & Findings for Health Gatherings - For Your Health After Cancer (NCT NCT03344757)
NCT ID: NCT03344757
Last Updated: 2025-09-11
Results Overview
Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
Baseline, Month 3, Month 6, Month 12
Results posted on
2025-09-11
Participant Flow
Participant milestones
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
88
|
|
Overall Study
COMPLETED
|
82
|
70
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
Reasons for withdrawal
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
16
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Health Gatherings - For Your Health After Cancer
Baseline characteristics by cohort
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.07 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
65.42 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
65.77 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Symptom Burden as Measure by EPIC-S.
Baseline
|
30.1 score on a scale
Standard Error 2.53
|
32.1 score on a scale
Standard Error 3.02
|
|
Change in Symptom Burden as Measure by EPIC-S.
Month 3
|
34.7 score on a scale
Standard Error 3.01
|
35.8 score on a scale
Standard Error 3.30
|
|
Change in Symptom Burden as Measure by EPIC-S.
Month 6
|
35.9 score on a scale
Standard Error 3.39
|
38.0 score on a scale
Standard Error 3.67
|
|
Change in Symptom Burden as Measure by EPIC-S.
Month 12
|
36.2 score on a scale
Standard Error 3.27
|
38.9 score on a scale
Standard Error 3.50
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in HRQoL as Measured by the FACT Questionnaire.
Baseline
|
81.1 score on a scale
Standard Error 1.12
|
81.7 score on a scale
Standard Error 1.70
|
|
Change in HRQoL as Measured by the FACT Questionnaire.
Month 3
|
83.8 score on a scale
Standard Error 1.30
|
83.7 score on a scale
Standard Error 1.45
|
|
Change in HRQoL as Measured by the FACT Questionnaire.
Month 6
|
83.6 score on a scale
Standard Error 1.51
|
83.3 score on a scale
Standard Error 1.74
|
|
Change in HRQoL as Measured by the FACT Questionnaire.
Month 12
|
82.6 score on a scale
Standard Error 1.41
|
83.0 score on a scale
Standard Error 1.54
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Symptom Burden as Measure by EPIC-UIN.
Baseline
|
73.5 score on a scale
Standard Error 2.45
|
78.8 score on a scale
Standard Error 2.32
|
|
Change in Symptom Burden as Measure by EPIC-UIN.
Month 12
|
78.3 score on a scale
Standard Error 2.41
|
83.3 score on a scale
Standard Error 2.31
|
|
Change in Symptom Burden as Measure by EPIC-UIN.
Month 3
|
77.4 score on a scale
Standard Error 2.50
|
82.2 score on a scale
Standard Error 2.38
|
|
Change in Symptom Burden as Measure by EPIC-UIN.
Month 6
|
79.5 score on a scale
Standard Error 2.47
|
84.6 score on a scale
Standard Error 2.18
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
Baseline
|
43.2 T-score
Standard Error 0.90
|
43.5 T-score
Standard Error 0.99
|
|
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
Month 3
|
43.3 T-score
Standard Error 0.88
|
42.8 T-score
Standard Error 1.06
|
|
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
Month 6
|
43.9 T-score
Standard Error 1.09
|
43.1 T-score
Standard Error 1.05
|
|
Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire
Month 12
|
43.5 T-score
Standard Error 0.96
|
43.0 T-score
Standard Error 0.99
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
Baseline
|
47.8 T-score
Standard Error 0.93
|
47.0 T-score
Standard Error 0.97
|
|
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
Month 3
|
46.7 T-score
Standard Error 0.96
|
46.4 T-score
Standard Error 1.08
|
|
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
Month 6
|
47.1 T-score
Standard Error 1.20
|
46.9 T-score
Standard Error 1.06
|
|
Change in HRQoL as Measured by the PROMIS Pain Questionnaire
Month 12
|
48.3 T-score
Standard Error 1.07
|
46.2 T-score
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Stress Management Skills as Measured by MOCS-A
Month 12
|
39.2 score on a scale
Standard Error 0.90
|
38.0 score on a scale
Standard Error 0.95
|
|
Change in Stress Management Skills as Measured by MOCS-A
Baseline
|
38.5 score on a scale
Standard Error 0.87
|
37.6 score on a scale
Standard Error 1.09
|
|
Change in Stress Management Skills as Measured by MOCS-A
Month 3
|
38.6 score on a scale
Standard Error 0.91
|
38.3 score on a scale
Standard Error 1.09
|
|
Change in Stress Management Skills as Measured by MOCS-A
Month 6
|
39.6 score on a scale
Standard Error 0.93
|
39.3 score on a scale
Standard Error 1.23
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
Baseline
|
7.1 score on a scale
Standard Error 0.94
|
10.0 score on a scale
Standard Error 1.20
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
Month 3
|
5.6 score on a scale
Standard Error 0.98
|
6.2 score on a scale
Standard Error 0.97
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
Month 6
|
5.01 score on a scale
Standard Error 0.93
|
7.7 score on a scale
Standard Error 1.24
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II
Month 12
|
6.7 score on a scale
Standard Error 1.08
|
6.1 score on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
Baseline
|
8.5 score on a scale
Standard Error 0.28
|
8.1 score on a scale
Standard Error 0.37
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
Month 3
|
8.9 score on a scale
Standard Error 0.31
|
9.1 score on a scale
Standard Error 0.33
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
Month 6
|
8.7 score on a scale
Standard Error 0.29
|
8.3 score on a scale
Standard Error 0.38
|
|
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III
Month 12
|
9.1 score on a scale
Standard Error 0.30
|
8.8 score on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
Baseline
|
44.8 score on a scale
Standard Error 0.91
|
45.9 score on a scale
Standard Error 0.96
|
|
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
Month 3
|
43.8 score on a scale
Standard Error 0.94
|
44.7 score on a scale
Standard Error 1.05
|
|
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
Month 6
|
44.8 score on a scale
Standard Error 1.05
|
45.4 score on a scale
Standard Error 1.12
|
|
Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire
Month 12
|
45.5 score on a scale
Standard Error 0.97
|
44.9 score on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
Baseline
|
49.5 score on a scale
Standard Error 0.98
|
50.0 score on a scale
Standard Error 1.08
|
|
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
Month 3
|
50.4 score on a scale
Standard Error 0.96
|
49.1 score on a scale
Standard Error 1.18
|
|
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
Month 6
|
51.0 score on a scale
Standard Error 1.16
|
49.8 score on a scale
Standard Error 1.24
|
|
Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire
Month 12
|
50.7 score on a scale
Standard Error 0.98
|
49.0 score on a scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: Not all participants completed every assessment/timepoint and some were lost to follow-up.
Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.
Outcome measures
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 Participants
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 Participants
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Change in Interpersonal Function as Measured the SIP Questionnaire
Baseline
|
2.5 score on a scale
Standard Error 0.28
|
3.1 score on a scale
Standard Error 0.38
|
|
Change in Interpersonal Function as Measured the SIP Questionnaire
Month 3
|
2.6 score on a scale
Standard Error 0.40
|
2.9 score on a scale
Standard Error 0.45
|
|
Change in Interpersonal Function as Measured the SIP Questionnaire
Month 6
|
2.2 score on a scale
Standard Error 0.30
|
2.5 score on a scale
Standard Error 0.40
|
|
Change in Interpersonal Function as Measured the SIP Questionnaire
Month 12
|
2.6 score on a scale
Standard Error 0.38
|
2.3 score on a scale
Standard Error 0.36
|
Adverse Events
Cultural-Cognitive Behavioral Stress Management (CCBSM)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cognitive Behavioral Stress Management (CBSM)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 participants at risk
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 participants at risk
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Cardiac disorders
Hypertension
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
Other adverse events
| Measure |
Cultural-Cognitive Behavioral Stress Management (CCBSM)
n=100 participants at risk
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
|
Cognitive Behavioral Stress Management (CBSM)
n=88 participants at risk
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
1.0%
1/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
0.00%
0/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
2.3%
2/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
2.3%
2/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/100 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
1.1%
1/88 • 1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place