Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Brief Pain Inventory (Modified for Joint Pain) Scores
研究概览
简要总结
The purpose of this pilot intervention study is to test the potential effectiveness of a self-management intervention (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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Enhanced Standard Care
Participants will receive standard care, plus a brochure about hormonal therapy use.
Treatment (Education plus Exercise)
Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.
干预措施: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) (Behavioral)
结局指标
主要结局
Change in Brief Pain Inventory (Modified for Joint Pain) Scores
时间窗: baseline at 12 months
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.
次要结局
- Change in Toronto Informational Needs Questionnaire (TINQ) Scores -- Breast Cancer(Month 12)
- Inflammatory biomarker amounts(Baseline and Month 12)
- Change in Exercise Self-efficacy Scale Scores(Month 12)
- AI Medication Adherence Percentage(Day 30)
- 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(Month 12)
- Change in Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Scores for Older Adults(Month 12)