REJOIN Trial for Older Breast Cancer Survivors

Breast Cancer Female Clinical Trial

— REJOIN  

Official title:

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03955627
• Other study ID #: IRB00089191
• Secondary ID: 40010042
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: Rebecca Dellinger, MS
• Phone: 336-713-0677
• Email: radellin[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Behavioral:
• Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)
Self-management program which includes supervised exercise sessions in groups and group discussions for 8 weeks conducted by Zoom video, followed by an 8-week home-based version of the same program participants do on their own with bi-weekly coaching calls.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Pain Inventory (Modified for Joint Pain) Scores	The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI-sf is a modification of the Brief Pain Inventory - Long Form, which includes additional questions on demographics (date of birth, marital status, education, employment), pain history, aggravating and easing factors, treatment and medication, pain quality, and response to treatment. Higher scores indicate greater severity and more interference.	baseline at 12 months
Secondary	AI Medication Adherence Percentage	Medication Possession Ratio (MPR). Percent of days medication taken as prescribed, as self-reported by patient and verified with prescription refill records.	Day 30
Secondary	Change in Toronto Informational Needs Questionnaire (TINQ) Scores -- Breast Cancer	Self-report questionnaire about knowledge of breast cancer, its treatment and its side effects. Responses to questions about informational needs are reported using a Likert Scale -- 1 is "not important" to 5 "extremely important." Higher score indicate greater informational needs. Individual subscales may be calculated using percentages.	Month 12
Secondary	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	Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors.	Month 12
Secondary	Change in Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Scores for Older Adults	This self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. Intensity is reflected in the item stem (e.g., light and heavy gardening are separate items).	Month 12
Secondary	Change in Exercise Self-efficacy Scale Scores	The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each of 8 items, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.	Month 12
Secondary	Inflammatory biomarker amounts	Fasting blood sample (2 tsp) to assess inflammatory biomarkers (IL-6, TNFa, C-reactive protein [CRP])	Baseline and Month 12