Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breast Cancer - Female
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Clinical Pilot. Enhanced Standard Care v. Treatment (education plus exercise).Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Masked parties will not be told the arm to which the participant is assigned. Patient study records will indicate if they are in the study, but not the arm assignment. All participants will receive standard information about AI use and participate in four assessments.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 65 years and 125 years
Gender
Only males

Description

To improve AIA and AI Adherence in older survivors, it will: first, adapt an evidence-based intervention (AIM 1) and then; test the adapted intervention with breast cancer survivors ?65 years. The Investigators will educate survivors about possible AI-related side effects and teach survivors ways to...

To improve AIA and AI Adherence in older survivors, it will: first, adapt an evidence-based intervention (AIM 1) and then; test the adapted intervention with breast cancer survivors ?65 years. The Investigators will educate survivors about possible AI-related side effects and teach survivors ways to use PA to self-manage AIA (AIM 2), and support adherence to hormonal therapy recommendations (AIM 3). Given evidence that survivors experience AIA soon after initiating hormonal therapy, potentially eligible participants would be identified early in the treatment process. By identifying potential participants after diagnosis or during active treatment, survivors would have a minimal delay in beginning the exercise intervention after initiating hormonal therapy (i.e. AIs). All participants will have completed surgery, radiation and/or chemotherapy, which is consistent with current ASCO guidelines for AI use. Two groups will be randomized to either an information-only group (enhanced standard care) or an education plus exercise group (treatment). At the initial clinical visit during the intervention, participants in both groups will receive printed information along with their AI medication prescription. The treatment group will subsequently receive a one-on-one exercise consultation with a certified exercise trainer (e.g ACSM or similar), followed by a modified version of the Fit & Strong! program, which includes bi-weekly supervised exercise (60 minutes) and educational sessions (30 minutes). The exercise sessions will include light weights or resistance bands plus low-impact aerobic exercise, in which movements will be explained, demonstrated and modified based on the needs of participants. The exercise protocol will be reviewed and revised based on recommendations from clinical advisers. Educational materials will provide information about the purpose of AI medications (e.g., to reduce cancer recurrence) in layperson language and basic information about potential side effects. As part of in-person sessions, participants will develop a plan to continue exercise at home. Participants can do an activity of their choice (e.g., walking) and use resistance bands which will be provided for the at-home program which will begin after 8 weeks and will include follow up phone calls to assess progress and reinforce the program. Educational sessions will be modified to reflect relevant content and advice for older survivors beginning AIs. Assessments will be taken at 4 and 6 months, with follow up at 12 months. All supervised exercise sessions will be conducted remotely to accommodate recommended COVID safety protocols.

Tracking Information

NCT #
NCT03955627
Collaborators
American Cancer Society, Inc.
Investigators
Principal Investigator: Shirley M. Bluethmann, PhD, MPH Milton S. Hershey Medical Center