Self-management Interventions for Advanced Breast Cancer

Not Applicable

Completed

• Conditions: Advanced Breast Cancer Stage IV

• Registration Number: NCT01927081
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Study Start: 2014-09
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability	36 months	Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
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

Secondary Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States