An Intervention to Decrease Fatigue Among Breast Cancer Survivors
An Intervention to Decrease Fatigue Among Breast Cancer Survivors
This research project is being done to design and then test whether a 10 week program can
 help reduce the symptoms of being tired and fatigued among women who have had breast cancer.
 The pilot study will include 4 groups of women, two groups of women from Baltimore and two
 groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The
 purpose of this pilot study is to help us find the best things to include in the program to
 help women who have had breast cancer and who have severe problems with fatigue that has
 lasted months to years after being treated with chemotherapy or radiation therapy.

 Following the pilot program we will conduct and evaluate (using a quasi-experimental design
 comparing fatigue scores before and after the intervention) the efficacy of the refined
 10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast
 cancer survivors who have completed their adjuvant therapy. Four intervention groups (~12
 women per group) will be conducted: two in the urban setting and two in the rural setting. We
 will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6
 months following completion of the program. We will compare mean baseline scores to
 post-intervention scores.

 The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for
 improving symptoms of fatigue and thus improving quality of life among breast cancer
 survivors
Research Question:

 Fatigue is a common, persistent symptom following treatment for breast cancer, challenging a
 women's ability to promptly regain her overall health and well-being. The aim of the study is
 to design, evaluate and implement an integrated mind-body medicine intervention to reduce
 symptoms of persistent fatigue.

 The research questions being addressed are: Can a 10 week mind-body medicine intervention
 program improve fatigue scores from the disability range to the non-disabled range and does
 the improvement in fatigue symptoms persist up to 6 months following the intervention?

 The aims of the study are to Aim I: Pilot test a 10 week mind/body medicine group
 intervention among 4 groups of breast cancer survivors with 5 women per group. Groups will be
 stratified by urban/rural setting (Baltimore region/Washington County), race (African
 American and White), and educational status. These pilot groups will evaluate the program to
 help refine the intervention to be comprehensible and culturally sensitive.

 Aim II: A 10-week intervention program will be developed specifically targeted to alleviate
 fatigue among breast cancer survivors. Weekly sessions of approximately 2 hours duration will
 be held. Four intervention groups with approximatley 12 women per group women will be
 conducted in two regions, an urban setting and a rural setting. The interventions will be
 conducted at the Women's Center for Health & Medicine at the Mercy Medical Center in downtown
 Baltimore and the Robinwood Outpatient Medical Facility in Hagerstown Maryland (Washington
 County.) The Women's center is located downtown Baltimore with access to public
 transportation as well as a having convenient parking with valet services. The Robinwood
 Center is also centrally located in Washington County near Hagerstown, MD.

 Rationale:

 Thirty-five percent of breast cancer survivors, between 1 and 5 years following the diagnosis
 of breast cancer report symptoms of fatigue that fall into the disability range, despite
 remaining disease-free (Bower 2000, Lindley 1998). There is a paucity of information on what
 interventions may be most useful in reducing fatigue symptoms. Most interventions have
 focused on one factor that may contribute to fatigue such as sleep disturbance or pain.
 Exercise interventions have been tried but have mostly focused on fatigue during chemotherapy
 or radiation therapy and have not addressed the problem of persistent fatigue.

 Fatigue is a complex, multi-dimensional symptom with several contributing factors. Pain,
 sleep disturbance, depression, decreased physical activity and menopausal symptoms are
 associated with fatigue (Couzi 1995, Servaes 2002, Bennett 2004 and Bower 2000). Therefore, a
 broad-based intervention program holds the most promise for alleviating fatigue. We propose
 to examine the efficacy of a holistic mind/body medicine approach to empower women to address
 many of the factors associated with fatigue and incorporate healthy behaviors into their
 routine to alleviate fatigue. The intervention is a 10 week program modeled after the
 Mind/Body Medicine program established by Dr. Herbert Benson of the Harvard-affliliated Mind
 Body Medicine Institute.

 Methods Study Design: Quasi-experimental: before/after study design.

 Population: The target population is women with breast cancer diagnosed within the past 5
 years. The eligibility criteria include:

 -  Women within 5 years of the diagnosis of breast cancer and currently disease free.

 -  Women must have completed chemotherapy and/or radiation therapy 6 months prior to
 joining the study.

 -  Women may be taking adjuvant hormonal therapy (e.g. tamoxifen or aromatase inhibitors)

 -  Women scoring less than 50 (consistent with servere fatigue leading to disability and
 limitations) on the energy/fatigue subscale of the SF-36 health survey (Appendix A).

 Intervention:

 Each session will last approximately 90 minutes. We will offer the sessions at the most
 convenient time for participants (e.g. early morning, lunch time or evening). The time will
 be established based on availability of the participants.

 Sample Size:

 The pilot study will recruit 5 women for each of 4 groups: Two urban groups, African American
 and White, and two rural groups, stratified by educational status (less than high school;
 high school graduate and higher). No formal sample size was calculated for the pilot study.
 The women will evaluate each session for comprehension and relevance to their situation (e.g.
 exercise interventions may vary significantly for an urban resident versus a rural resident).
 Following the completion of the 10 week program we will also ask each woman to evaluate the
 program as a whole.

 Sample size calculations for the main intervention component were based on results of a
 survey of fatigue and quality of life among breast cancer survivors 1 to 5 years following
 the diagnosis of breast (Bower 2000). That study used the energy/fatigue subscale of the
 SF-36 Health Survey (Ware 1992.). That instrument has also been shown to correlate with the
 Piper fatigue scale, an instrument specifically designed and evaluated among breast cancer
 patients (Piper 1998). We will administer both survey instruments but will base sample size
 estimates on the SF-36, a more widely used health survey instrument.

 The SF-36 energy/fatigue subscale defines disability/limitation as scores under 50. In a
 survey of breast cancer survivors, women classified as disabled due to fatigue (scoring less
 than 50 on the subscale) had a mean score of 37 (Bower 2000.) Overall, in that study, breast
 cancer survivors had a mean score of 60 (standard deviation 20). Women who fall into the
 disabled range of the energy/fatigue subscale will be recruited for this study. We estimate
 that the intervention will improve mean scores to a level of 50/51 (average 14 point
 improvement) to the non-disabled range. We will compare mean scores before and after the
 intervention session. Assuming a mean score of 37 and a projected mean score improvement of
 14 points 10 women per intervention group will give a power of 80% to detect a mean
 difference of 14 points (using paired-t-test). We will recruit 12 patients per group,
 allowing for potential dropouts during the intervention. Thus each of 4 groups of women
 should provide adequate power to detect a meaningful clinical improvement in fatigue scores.

 Recruitment:

 Women will be recruited through the Hoffberger Breast Center, the Medical Oncology Practice
 at Mercy, and, for Washington County, through the John Marsh Cancer Center.
Inclusion Criteria:

 moderate to severe fatigue >6 months after last chemotherapy or radiation treatment >5
 years from diagnosis

 -

 Exclusion Criteria:

 Metastatic disease-