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Self-management Interventions for Advanced Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 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: February 24, 2017
Last verified: February 2017
  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 Stage IV
Behavioral: discussion group
Behavioral: gentle exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ]
    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

  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 65
Study Start Date: September 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2018 (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   (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
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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01927081     History of Changes
Other Study ID Numbers: Pro00044446
Study First Received: August 16, 2013
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2017