Self-management Interventions for Advanced Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2014 by Duke University

Sponsor:

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: October 17, 2014

Last verified: October 2014

History of Changes

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	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

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 2018
Estimated Primary Completion Date:	September 2017 (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
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of Stage IV breast cancer or recurrent metastatic breast cancer,
receiving care at Duke Cancer Institute,
life expectancy ≥9 months as estimated by the treating oncologist,
usual pain rating over the past 2 weeks of at least 3 on a 0-10 scale,
speak and read English,
be at least age 18

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,
metastases to the brain,
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

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

No publications provided


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01927081 History of Changes
Other Study ID Numbers:	Pro00044446
Study First Received:	August 16, 2013
Last Updated:	October 17, 2014
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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