Clinical trial NCT03955627: REJOIN Trial for Older Breast Cancer Survivors
Official title: Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Cancer Treatment Symptoms, Symptom Management
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2019-05-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Pilot. Enhanced Standard Care v. Treatment (education plus exercise).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited from local cancer clinics prior to the completion of primary cancer treatment, as arthralgia can occur soon after initiating AI medication. Participants will be randomized to one of two groups: an enhanced standard care group (AI prescription plus information) or a treatment group (educational classes plus group exercise sessions). Older survivors (≥60 years) will be targeted because they are at increased risk of medication complications which may impede adherence. For the baseline assessment, a cancer-specific geriatric assessment will be conducted and a blood sample will be collected to interpret the effects of the self-management study in the context of geriatric experiences. Additionally, there will be an assessment of knowledge, PA habits, and AI-related joint pain and AI adherence. These will be measured again at 4, 6 and at follow up at 12 months.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Female, aged ≥ 60 years at the start of study
* Planning to initiate AIs
* Diagnosed stages I-III Breast Cancer
* R+ tumor (at least 5% of cells)
* Completed surgery, radiation and/or chemotherapy
* Independent ambulatory (verified by treating clinician/staff)
* Physician approval to start an exercise program
* Must report insufficient physical activity (\<150 min. of physical activity per week)
* Able to complete surveys and forms/ understand English
* Agree to random assignment to exercise or control group
* Can commit to 8 weeks, bi-weekly classes offered by Zoom video
* Must have internet access and/or data plan by which to participate in Zoom video sessions
* Minimum cognitive impairment (verified by cognitive screening questions administered by phone or in-person interview)

Exclusion Criteria:

* Already taking Aromatase Inhibitors (AIs) (may participate if 24 weeks or less after initiating)
* Presence of metastatic cancer or concurrent malignancy requiring treatment
* Recent history (past 6 months) of stroke/ Myocardial Infarction (MI), atrial fibrillation or class 3, 4 heart failure
* Recent joint surgery or conditions limiting PA

Primary outcomes:
measure: Change in Brief Pain Inventory (Modified for Joint Pain) Scores
timeFrame: baseline at 12 months
Secondary outcomes:
measure: AI Medication Adherence Percentage
timeFrame: Day 30
measure: Change in Toronto Informational Needs Questionnaire (TINQ) Scores -- Breast Cancer
timeFrame: Month 12
measure: Change in Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire
timeFrame: Month 12
measure: Change in Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Scores for Older Adults
timeFrame: Month 12
measure: Change in Exercise Self-efficacy Scale Scores
timeFrame: Month 12
measure: Inflammatory biomarker amounts
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Shirley M Bluethmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bluethmann SM, Truica C, Klepin HD, Olsen N, Sciamanna C, Chinchilli VM, Schmitz KH. Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial. J Geriatr Oncol. 2021 Sep;12(7):1146-1153. doi: 10.1016/j.jgo.2021.05.011. Epub 2021 May 26.