Self-management Interventions for Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT01927081 |
Recruitment Status
:
Completed
First Posted
: August 22, 2013
Last Update Posted
: December 4, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Breast Cancer Stage IV | Behavioral: discussion group Behavioral: gentle exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Self-management Interventions for Pain in Advanced Breast Cancer |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | November 20, 2017 |
Actual Study Completion Date : | November 20, 2017 |

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
|
Behavioral: discussion group
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
|
Behavioral: discussion group
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
Behavioral: gentle exercise
Patients learn gentle exercise and breathing techniques
|
- 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
- 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

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927081
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27708 |
Principal Investigator: | Laura Porter, PhD | Duke University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01927081 History of Changes |
Other Study ID Numbers: |
Pro00044446 |
First Posted: | August 22, 2013 Key Record Dates |
Last Update Posted: | December 4, 2017 |
Last Verified: | February 2017 |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |