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:
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
  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:


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
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 October 22, 2014