Completed

NCT Number: NCT01927081

Self-management Interventions for Advanced Breast Cancer

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.

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Key information

Conditions

Advanced Breast Cancer Stage IV

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

discussion group

Behavioral

Participants engage in discussions regarding issues related to coping with advanced cancer and pain

gentle exercise

Behavioral

Patients learn gentle exercise and breathing techniques

Primary outcomes

Feasibility

Time frame: 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

Time frame: 36 months

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

Secondary outcomes

Change in pain

Time frame: 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 fatigue

Time frame: 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 sleep disturbance

Time frame: 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 Psychological distress

Time frame: 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 functional capacity

Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

Functional capacity assessed using a 6-minute walk test

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Self-management Interventions for Pain in Advanced Breast Cancer

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Aug 22, 2013
Registry last updated: Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.