There are more than 2.4 million breast cancer (BrCa) survivors living in the U.S. today. As a common and morbid effect of BrCa treatment, lymphedema ranks principal among concerns of long-term survivors. Lymphedema causes limb swelling and discomfort, significantly impairing arm function. Though incidence is commonly quoted to be between 20-30%, lymphedema negatively affects all BrCa survivors because risk factors are ill-defined and the condition is chronic, progressive, and incurable. Breast cancer survivors have long been advised by clinicians to avoid lifting with the affected arm to avoid onset or worsening of lymphedema. The results of the recently completed Physical Activity and Lymphedema Trial (PAL) provide compelling evidence that this well-meaning risk-averse advice to avoid lifting was in error. The PAL Trial established the effectiveness of a weight-training intervention to prevent lymphedema flare-ups in a study with a large sample size. The weight-training intervention also improved muscle strength and self perception of strength and health, appearance and sexuality. Media attention and formative assessment work indicate that the breast cancer patient and clinician communities are interested in broad dissemination of this innovative intervention if it can be done safely. The next step is to develop and assess communication channels and infrastructure for a revised method of PAL intervention delivery that is broadly disseminable, emphasizes safety and is still effective. This exploratory study will pilot test a revised intervention delivery approach specifically informed by clinician and survivor concerns for safety. During an oncology follow-up visit, survivors seen at the Rena Rowan Breast Center will receive a referral from an oncology clinician for a standardized physical therapy evaluation (and treatment, if needed) of arm and shoulder problems, including but not limited to lymphedema. After clearance from a physical therapist, 120 survivors will participate in four group physical therapy sessions. During these sessions, survivors will learn essential elements of safe and effective performance of the PAL weight-training protocol. After this, each woman will be provided options to participate in the PAL weight-lifting program in their home or at a community YMCA. The cost of the physical therapy evaluation, treatment (if needed), and group sessions to learn the PAL weight-lifting program will all be paid for by the participant's insurance. As this is not a part of their curative therapy (e.g., it is optional), it is anticipated that some survivors will choose not to participate in some or all of this offered intervention. Data will be collected to help explain what elements of the proposed approach facilitate or prevent broader dissemination and uptake of this approach to delivering the PAL intervention. Evaluation of the intervention will be guided by Dissemination of Innovation Model constructs that help explain dissemination success, including relative advantage, compatibility, complexity, trialability, and observed results. Results of this pilot study will be used to further revise the PAL intervention delivery approach to develop a larger dissemination trial.

Public Health Relevance

The exciting results of the recently completed Physical Activity and Lymphedema (PAL) trial have been received enthusiastically by the breast cancer clinical treatment and survivorship communities. However, there are questions as to how best to deliver this successful, safe, and effective YMCA based weight-lifting intervention for breast cancer survivors. The proposed exploratory study is intended to test an intervention delivery system that will reach many survivors, emphasizes patient safety, and still links the survivor back to her community YMCA for long-term support of weight-lifting activities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21CA152451-02
Application #
8248691
Study Section
Community-Level Health Promotion Study Section (CLHP)
Program Officer
Alfano, Catherine M
Project Start
2011-04-01
Project End
2013-09-30
Budget Start
2012-04-01
Budget End
2013-09-30
Support Year
2
Fiscal Year
2012
Total Cost
$174,000
Indirect Cost
$65,250
Name
University of Pennsylvania
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Beidas, Rinad S; Paciotti, Breah; Barg, Fran et al. (2014) A hybrid effectiveness-implementation trial of an evidence-based exercise intervention for breast cancer survivors. J Natl Cancer Inst Monogr 2014:338-45