Back to resultsSelf-management Interventions for Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer Stage IV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
discussion group
gentle exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Breast Cancer Stage IV
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
discussion group
discussion group + exercise
Arm Description
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
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
Outcomes
Primary Outcome Measures
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
Acceptability
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
Secondary Outcome Measures
Change in pain
pain intensity as assessed by the Brief Pain Inventory
Change in fatigue
Fatigue as assessed by the Brief Fatigue Inventory
Change in sleep disturbance
Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index
Change in Psychological distress
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale
Change in functional capacity
Functional capacity assessed using a 6-minute walk test
Full Information
NCT ID
NCT01927081
First Posted
August 16, 2013
Last Updated
October 8, 2018
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01927081
Brief Title
Self-management Interventions for Advanced Breast Cancer
Official Title
Self-management Interventions for Pain in Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer Stage IV
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
discussion group
Arm Type
Active Comparator
Arm Description
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
Arm Title
discussion group + exercise
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
discussion group
Intervention Description
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
Intervention Type
Behavioral
Intervention Name(s)
gentle exercise
Intervention Description
Patients learn gentle exercise and breathing techniques
Primary Outcome Measure Information:
Title
Feasibility
Description
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
Time Frame
36 months
Title
Acceptability
Description
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Change in pain
Description
pain intensity as assessed by the Brief Pain Inventory
Time Frame
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Title
Change in fatigue
Description
Fatigue as assessed by the Brief Fatigue Inventory
Time Frame
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Title
Change in sleep disturbance
Description
Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index
Time Frame
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Title
Change in Psychological distress
Description
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale
Time Frame
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Title
Change in functional capacity
Description
Functional capacity assessed using a 6-minute walk test
Time Frame
study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Porter, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28288595
Citation
Carson JW, Carson KM, Olsen MK, Sanders L, Porter LS. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial. BMC Complement Altern Med. 2017 Mar 13;17(1):153. doi: 10.1186/s12906-017-1672-9.
Results Reference
derived
Learn more about this trial
Self-management Interventions for Advanced Breast Cancer
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