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Fatigue Intervention Trial for Breast Cancer Survivors

M

Mercy

Status and phase

Completed
Phase 3

Conditions

Fatigue

Treatments

Behavioral: Group based mind body medicine intervention
Behavioral: Group-based mind body medicine intervention + family focus

Study type

Interventional

Funder types

Other

Identifiers

NCT00513136
MMC2007-46

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

I
Active Comparator group
Description:
10 week group-based mind body medicine intervention
Treatment:
Behavioral: Group based mind body medicine intervention
II
Experimental group
Description:
Group-based mind body medicine intervention with a family focus
Treatment:
Behavioral: Group-based mind body medicine intervention + family focus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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