Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors

Breast Carcinoma Clinical Trial

Official title:

Developing an Intervention to Reduce Stress and Improve Quality of Life in Underserved Urban Latina Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521961
• Other study ID #: 9425
• Secondary ID: NCI-2015-01183P3
• Status: Completed
• Phase: N/A
• Start date: February 3, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: October 2018
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Latino

• Spanish-speaking

• Diagnosed with breast cancer

• A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least 3 months following study enrollment

• Additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant)

• There will be no restrictions on time since diagnosis for participants

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Cancer Survivor

Intervention

Other:
• Informational Intervention
Watch a Chair-robics DVD
• Informational Intervention
Receive community resource booklet
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Support Group Therapy
Attend support group sessions

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence assessed using weekly attendance records	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Up to 10 weeks
Primary	Change in acculturation to reflect language use and media, as well as ethnic social relationships, assessed using the Short Acculturation Scale for Hispanics	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in anxiety, measured using the Generalized Anxiety Disorder-7	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in coping style, assessed using the Brief Cope scale	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in depression assessed using the Patient Health Questionnaire depression module-9	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in distress assessed using the Distress Thermometer measure	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in fatigue assessed using the FACIT	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in Hispanic-specific stress measured using the abbreviated version of the Hispanic Stress Inventory-Immigrant version	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in perceived stress measured using the Perceived Stress Scale	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in quality of life as measured using the Functional Assessment Chronic Illness Therapy (FACIT)-General	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in self-efficacy measured using the Spanish Chronic Disease Self-Efficacy scale	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks
Primary	Change in social support assessed using the Medical Outcomes Study-Social Support Survey	Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses.	Baseline to up to 10 weeks