Fatigue Intervention Trial for Breast Cancer Survivors

December 11, 2019 updated by: Michael Mullen, Mercy Medical Center

A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors

Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery.

The investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to address the persistent fatigue experienced by brest cancer survivors by using a 10 week group-based mind body medicine intervention that includes the family in the process. We believe that this family-centered approach can facilitate better communication, create shared illness experience and relieve conflict. Reducing this pervasive source of stress will not only reduce the survivor's fatigue, but also foster an opposite family dynamic with positive effects in many other aspects of post-treatment recovery. We will compare the effectiveness of a 10 week group intervention to a 10 week group intervention that includes a family focus.

Breast cancer survivors with moderate to severe fatigue will be randomly assigned to one of the two groups and we will measure change in fatigue, quality of life, mood and social support from baseline to end-of-program and then two and six months after program completion.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21093
        • Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage I-III Breast Cancer
  • At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
  • 4 week history of persistent moderate to severe fatigue
  • Competent to sign informed consent
  • Willing to be randomized

Exclusion Criteria:

  • Metastatic breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: I
10 week group-based mind body medicine intervention
Behavioral: Group based mind body medicine intervention
Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns
EXPERIMENTAL: II
Group-based mind body medicine intervention with a family focus
Behavioral: Group-based mind body medicine intervention + family focus
In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Change from baseline to end-of-intervention and 2 and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life; Mood; Social Support
Time Frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention
Change from baseline to end-of-intervention and 2 and 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Medical Center

Investigators

  • Principal Investigator: Kathy J Helzlsouer, MD, MHS, Mercy Medical Center
  • Principal Investigator: Julianne Oktay, PhD, MSW, University of Maryland School of Social Work

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (ESTIMATE)

August 8, 2007

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC2007-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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