Self-management Interventions for Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.

Official Title
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Self-management Interventions for Pain in Advanced Breast Cancer

Conditions
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Advanced Breast Cancer Stage IV

Intervention / Treatment
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* Behavioral: discussion group
* Behavioral: gentle exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Stage IV breast cancer or recurrent metatastic breast cancer receiving care at Duke Cancer Institute, life expectancy ≥9 months as estimated by the treating oncologist, speak and read English, be at least age 18 be able to travel to the Duke Cancer Institute Exclusion Criteria: cognitive impairment as assessed by the 6-item Mini-mental Status Exam, Karnofsky Performance Rating of <60 as rated by the oncology provider, an ECOG rating of 0-2 treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months, currently engaged in yoga practice ≥ 1 day per week

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: discussion group<br>Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain | Behavioral: discussion group<br>* Participants engage in discussions regarding issues related to coping with advanced cancer and pain<br>|
| Active Comparator: discussion group + exercise<br>Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques | Behavioral: discussion group<br>* Participants engage in discussions regarding issues related to coping with advanced cancer and pain<br>Behavioral: gentle exercise<br>* Patients learn gentle exercise and breathing techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥4 of 8 sessions and providing post-test assessments | 36 months | 
| Acceptability | Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | pain intensity as assessed by the Brief Pain Inventory | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | 
| Change in fatigue | Fatigue as assessed by the Brief Fatigue Inventory | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | 
| Change in sleep disturbance | Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | 
| Change in Psychological distress | Anxiety and depression assessed using the Hospital Anxiety and Depression Scale | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | 
| Change in functional capacity | Functional capacity assessed using a 6-minute walk test | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |