Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-22 @ 3:09 AM
Study NCT ID:
NCT02521961
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Developing an Intervention to Reduce Stress and Improve Quality of Life in Underserved Urban Latina Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial studies a support group program in improving quality of life in underserved urban Latina breast cancer survivors. A psychosocial support group program may help reduce distress and improve health-related quality of life in underserved urban Latina breast cancer survivors.
Detailed Description:
PRIMARY OBJECTIVES:
I. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of health-related quality of life.
II. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of general distress.
SECONDARY OBJECTIVES:
I. A brief qualitative assessment will evaluate the perception of the program among intervention participants using a brief survey.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. The sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. Participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a Chair-robics digital video disc (DVD).
ARM II: Participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. Participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to Arm I.
I. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of health-related quality of life.
II. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of general distress.
SECONDARY OBJECTIVES:
I. A brief qualitative assessment will evaluate the perception of the program among intervention participants using a brief survey.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. The sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. Participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a Chair-robics digital video disc (DVD).
ARM II: Participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. Participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to Arm I.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-01183 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |