Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Acceptability of the intervention and the study
研究概览
简要总结
Phase 2 randomized controlled study using a waitlist control group. The study also has a single arm pre-post test 12-week chair-based exercise arm for those who have received the geriatric assessment in the older adults with cancer clinic (geriatric oncology clinic).
Study Duration 2.5 years
Study Agent/ Intervention/ Procedure Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.
详细描述
The purpose of this randomized clinical trial is to compare the standard of care alone to using a detailed health assessment for older adults followed by a 12 week program of online physical activity and health education (also called the intervention) plus the standard of care. The addition of the detailed health assessment for older adults followed by a 12 week program of online physical activity and health education to the standard of care could benefit older adults with cancer in terms of improving their physical activity, muscle strength, quality of life, and fatigue.
The intervention group will receive a detailed health assessment for older adults followed by a 12- week program of physical activity and health education. During the assessment they will be asked to provide information on current health, mood, weight loss, vision and hearing, memory, fatigue, pain, and a review of medications. Additionally, they will be asked to undergo a few tests that assess walking, grip strength, and balance and complete questionnaires that evaluate quality of life, fatigue, anxiety, depression, and physical function.
Two weekly sessions of group-based exercise (20-40) minutes are conducted via Zoom by a qualified exercise professional. These sessions include aerobic exercise for 20 minutes; resistance training, for 10 minutes; balance training 8 minutes, and flexibility training for 7 minutes. They will receive a weekly check-in to discuss the exercises and progress with the QEP who will adjust the exercises based on tolerance. During the first session of each of the 12- weeks, a video about a health topic by an expert will be shown on Zoom so that they can think about it after the class and prepare questions for the discussion with the expert.
Their support person are invited to participate in this study. We assume that involving support persons in this study, including exercising together, can improve the health and quality of life of the patient and and their support person. If they or their support person do not have a tablet/laptop to join the class, this will be provided along with training on how to use them.
The control group will receive usual care and the option to receive the intervention after 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study statistician will be blinded to group allocation
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65+ years.
- •Diagnosed with lung, gastrointestinal (GI) , breast, Gynecologic or Genitourinary (GU) cancer or lymphoma who are referred for chemotherapy or immunotherapy and have not received > 4 weeks of systemic treatment.
- •4) Have a physician estimated life expectancy of >6 months. 5) Be physically inactive (no more than 90 min moderate to vigorous activity per week as per GLTEQ and do not currently meet the recommended physical activity volume of 90 min of aerobic exercise/week).
- •6) Able to speak and understand English. 7) Able to give informed consent. 8) Are considered safe to participate in the weekly classes as per their treating oncologist.
- •Eligible support persons are:
- •Identified by the older adult as their support person.
- •Aged 18 years and over.
- •Able to speak and understand English.
- •Able to give informed consent.
排除标准
- •Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and
- •Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention).
- •Chest tube in-situ.
- •Exclusion criteria support person:
- •Not able to give informed consent.
研究组 & 干预措施
Intervention group
geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy
干预措施: GAM, exercise, health education (Behavioral)
Waitlist control group
Wait list, receiving standard of care and option to receive intervention after treatment.
single arm pre-post test study for participants recruited from geriatric oncology clinic
They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment
干预措施: online chair-based exercise combined with health education (Behavioral)
结局指标
主要结局
Acceptability of the intervention and the study
时间窗: 12 weeks
What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log. A 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified. Acceptability will be defined as 1) adherence to the intervention of \>85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.
Feasability of the study
时间窗: 12 weeks
What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100. Feasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100. Feasibility of the study will be defined as recruitment of \>60% of all eligible older adults; retention of \>80% of the dyads; and 3) capture of outcome data of 80% or more.
次要结局
- Effect intervention on number of self-reported Falls(12 weeks)
- Effect intervention on Physical function(12 weeks)
- Effect intervention on Grip strength(12 weeks)
- Effect intervention on Life space Mobility(12 weeks)
- Effect of the intervention on Quality of life(12 weeks)
- Effect intervention on Physical Activity(12 weeks)
- Effect of the intervention on treatment toxicity(12 weeks)
- Effect of the intervention on Fatigue(12 weeks)
- Effect of the intervention on unplanned healthcare utilization(12 weeks)
研究者
Martine Puts
Professor
University of Toronto