Self-management Interventions for Advanced Breast Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Advanced Breast Cancer Stage IV	Behavioral: discussion group; Behavioral: gentle exercise	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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
2. Acceptability [ Time Frame: 36 months ]
   Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
Duke University Medical Center
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01927081 History of Changes
Other Study ID Numbers:	Pro00044446
First Posted:	August 22, 2013
Last Update Posted:	December 4, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases