Self-management Interventions for Advanced Breast Cancer
October 8, 2018 updated by: Duke University
Self-management Interventions for Pain in 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: discussion group
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
|
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
|
|
Active Comparator: discussion group + exercise
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
|
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
Patients learn gentle exercise and breathing techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
36 months
|
|
Acceptability
Time Frame: 36 months
|
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
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
|
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
|
|
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
|
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
|
|
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
|
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
|
|
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
|
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
|
|
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
|
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura Porter, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
November 20, 2017
Study Completion (Actual)
November 20, 2017
Study Registration Dates
First Submitted
August 16, 2013
First Submitted That Met QC Criteria
August 19, 2013
First Posted (Estimate)
August 22, 2013
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00044446
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.