Advanced Breast Cancer Stage IV
Conditions
Brief summary
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.
Interventions
BEHAVIORALdiscussion group
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
BEHAVIORALgentle exercise
Patients learn gentle exercise and breathing techniques
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 36 months | 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 |
| Acceptability | 36 months | Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep disturbance | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index |
| Change in pain | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | pain intensity as assessed by the Brief Pain Inventory |
| Change in functional capacity | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | Functional capacity assessed using a 6-minute walk test |
| Change in Psychological distress | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | Anxiety and depression assessed using the Hospital Anxiety and Depression Scale |
| Change in fatigue | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months | Fatigue as assessed by the Brief Fatigue Inventory |
Countries
United States
Outcome results
None listed