Fatigue After Adjuvant Breast Cancer Treatment Clinical Trial
Official title:
Being Well, Staying Healthy: An Integrated Mind-Body Medicine Intervention to Decrease Fatigue Among Breast Cancer Survivors, PILOT STUDY
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label