Evaluating the Implementation of a Need-based Cancer Survivorship Program Using the REAIM Framework
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,500
- 试验地点
- 5
- 主要终点
- Reach: The percentage of eligible patients being assessed, advised, and referred based on need.
研究概览
简要总结
The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.
详细描述
This study aims to implement the survivorship program through collaboration with NGOs and District Health Centers. The implementation of a need-based cancer survivorship program involves structured screening and needs assessment, with a focus on symptom distress and weight-related concerns. Based on identified needs, appropriate service referrals will be made to ensure timely and targeted support for cancer survivors.
The program is a prospective implementation study using both quantitative and qualitative methods, guided by the RE-AIM framework. The program plans to screen approximately 12,500 cancer survivors. The program will use the Edmonton Symptom Assessment System (ESAS) to identify symptom distress and a new diagnostic framework for weight-related concerns, with referrals made to JCICC or NGO/DHC partners for moderate-to-high needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Cancer patients)
- •Chinese/English speaking adult cancer patients aged 18 years or older
- •Within three years post-treatment attending the specialized outpatient clinics for surveillance
排除标准
- •(Cancer patients)
- •Non-Chinese or non-English speaking
- •Childhood cancer survivors
- •More than three years post-treatment
- •and/or unable to provide informed consent
- •Inclusion Criteria: (Peer volunteers)
- •Aged 18 years or older
- •Able to communicate in Chinese or English
- •Have lived experience as a cancer survivor or caregiver
研究组 & 干预措施
Low needs
Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is less than 4 and the BMI falls within the normal range (18.5-22.9), the patient will be categorized as Low needs. No referral will be made to NGO/DHCs; instead, the patient will receive two leaflets-one on diet and one on emotional well-being.
Moderate needs
Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is between 4 and 6 (inclusive) and the BMI indicates overweight status (23-24.9), the patient will be categorized as Moderate needs.
干预措施: Moderate needs intervention (Behavioral)
High needs
Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is equal to or greater than 7 and the BMI indicates obesity (25 or higher), the patient will be categorized as High needs.
干预措施: High needs (Behavioral)
结局指标
主要结局
Reach: The percentage of eligible patients being assessed, advised, and referred based on need.
时间窗: From enrollment to 36 months upon enrollment
Reach will be assessed as the percentage of eligible patients being assessed, advised, and referred based on need. Clinical units will submit weekly records of eligible patients assessed, advised, and referred to JCICC/NGO/DHC partners. The investigators will measure referral uptake through the proportion of patients accepting moderate- and high-need programs, examining attendance patterns and attrition rates. Weekly records will be collected from JCICC and NGO/DHC partners.
Adoption: The proportion of intervention agents willing to initiate the program,
时间窗: Assessed yearly during the 5-year study period
Adoption refers to the proportion of intervention agents willing to initiate the program, including patient volunteers, HCPs from clinical units, and NGO partner staff. For patient volunteers, the investigators assessed enrollment and training completion rates, requiring minimum 50% enrollment by potential active members. For HCPs and NGO/DHC staff, the investigators will calculate participation rates. The acceptability, appropriateness, and feasibility will be measured using the four-item Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). Each item is rated on a 5-point Likert scale ranging from 1 to 5 to measure the agreeability, with higher scores indicating greater acceptability, appropriateness, and feasibility.
Effectiveness: Need-based cancer survivorship program will be assessed on patients' outcomes
时间窗: Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.
Effectiveness of need-based cancer survivorship program will be assessed on patients' outcomes including symptom distress, weight control, health-related quality of life, work productivity and activity impairment, lifestyle changes (such as physical activity levels, diet quality, alcohol consumption, and smoking habits), knowledge and awareness of symptom management and overall health condition, satisfaction with services received, and health care utilization.
次要结局
- Symptom distress: The Edmonton Symptom Assessment System (ESAS)(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)
- Weight control - Weight, Height, and Body Mass Index (BMI)(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)
- Health-related quality of life: The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) and generic EQ-5D-5L questionnaire(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)
- Work productivity and activity impairment: The Chinese version of the Work Productivity and Activity Impairment (WPAI) questionnaire(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)
- Lifestyle changes (e.g. physical activity levels, diet quality, alcohol consumption, and smoking habits)(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)
- Knowledge and awareness of symptom management and overall health condition: To assess patients' knowledge, skills, and confidence in managing their health(Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.)