Self-management Interventions for Advanced Breast Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by Duke University
Sponsor:
Duke University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01927081
First received: August 16, 2013
Last updated: August 1, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Advanced Breast Cancer Stage IV |
Behavioral: discussion group Behavioral: gentle exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Self-management Interventions for Pain in Advanced Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Feasibility [ Time Frame: 36 months ] [ Designated as safety issue: No ]Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥7 of 8 sessions and providing post-test assessments
- Acceptability [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 [ Time Frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Functional capacity assessed using a 6-minute walk test
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2014 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927081
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927081
Contacts
| Contact: Jessyka Glatz, MA | 919-416-3434 | glatz001@mc.duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27708 | |
Sponsors and Collaborators
Duke University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Laura Porter, PhD | Duke University |
More Information
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01927081 History of Changes |
| Other Study ID Numbers: | Pro00044446 |
| Study First Received: | August 16, 2013 |
| Last Updated: | August 1, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 26, 2016