Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-089
Prinicipal Investigator
Olsen, Nancy
Phase
Pilot
Age Group
Adult
Scope
Local
Title
Using Exercise to Improve Arthralgia and AI Adherence in Older Breast Cancer Survivors
Objective
Study Objectives

The purpose of this pilot intervention study (n=76) is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving AI-induced arthralgia in older breast cancer survivors (≥65 years).
Aim 1: Adapt an evidence-based PA intervention based on educational needs of older cancer survivors planning to take AIs. The steps will include; a) Conduct a needs assessment (short survey) with older survivors who are eligible for adjuvant hormonal therapy to develop educational content on AIs and arthralgia; b) Add a geriatric assessment to the curriculum for all participants; c) Conduct an open pilot to pre-test suitability of adapted module with potential users. Based on user feedback, the module will be revised prior to testing.
Aim 2: Test the effect of a pilot intervention on arthralgia and behavioral predictors for AI medication adherence (e.g., knowledge and self-efficacy).
Hypothesis 1: Participants in the treatment group will have less arthralgia/joint pain than controls.
Hypothesis 2: Participants in the treatment group will have more knowledge and better self-efficacy to use exercise to manage arthralgia than controls.
Aim 3: Test the effect of a pilot intervention on adherence to aromatase inhibitors.
Hypothesis 3: Participants in the treatment group will have better adherence than controls.
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center