A Phase 3 interventional study of Group based mind body medicine intervention and Group-based mind body medicine intervention + family focus in Fatigue, sponsored by Mercy Medical Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Mercy Medical Center · Phase 3, Interventional, and Treatment
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.
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.
1,859 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 36 is below the median of 54 across 1,439 interventional studies indexed under Fatigue.
Browse Fatigue studies →Mercy Medical Center is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 week group-based mind body medicine intervention
Behavioral: Group based mind body medicine intervention
Group-based mind body medicine intervention with a family focus
Behavioral: Group-based mind body medicine intervention + family focus
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
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.
Fatigue
Time frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Quality of Life; Mood; Social Support
Time frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Mercy Medical Center