ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-management Interventions for Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01927081
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Top of Page 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
Go to 
Top of Page 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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927081


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
Go to 
Top of Page 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):

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

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