Self-management Interventions for Advanced Breast Cancer

Advanced Breast Cancer Stage IV Clinical Trial

Official title:

Self-management Interventions for Pain in Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927081
• Other study ID #: Pro00044446
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 20, 2017

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer Stage IV
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability	Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview	36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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