Self-management Interventions for Advanced Breast Cancer

Self-management Interventions for Pain in Advanced Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer Stage IV
• Intervention / Treatment: Behavioral: discussion group; Behavioral: gentle exercise

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months
Acceptability	Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	pain intensity as assessed by the Brief Pain Inventory	study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in fatigue	Fatigue as assessed by the Brief Fatigue Inventory	study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in sleep disturbance	Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index	study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in Psychological distress	Anxiety and depression assessed using the Hospital Anxiety and Depression Scale	study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in functional capacity	Functional capacity assessed using a 6-minute walk test	study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Laura Porter, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00044446