The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility outcomes
研究概览
简要总结
Young adults aged 18-39 years with cancer often experience physical, psychological, and social challenges that affect their participation in everyday life and their health-related quality of life. Existing cancer rehabilitation services are rarely tailored to the specific needs of this age group. The Young Adults Taking Action (YATAC) programme was developed together with young adults with cancer, healthcare professionals, and researchers to provide age-specific rehabilitation that supports young adults in managing cancer-related challenges and returning to everyday life.
The aim of this pilot randomized controlled trial is to evaluate the feasibility of conducting a larger trial of the YATAC programme in a municipal rehabilitation setting. The study will examine recruitment, retention, acceptability of randomization, data completeness, assessment burden, and adverse events. In addition, the study will provide preliminary estimates of the programme's effects on health-related quality of life and self-efficacy.
Fifty young adults aged 18-39 years who are undergoing or have completed curative-intent treatment will be recruited through municipal cancer rehabilitation services in Aarhus Municipality, Denmark. Participants will be randomly assigned to receive either the 16-week YATAC programme or usual cancer rehabilitation services. The YATAC programme includes an individual needs assessment and goal setting, followed by group-based and individual sessions addressing physical activity, fatigue, sleep and cognitive challenges, mental health, sexuality and relationships, family and friends, nutrition, and education or work. Outcomes will be assessed at baseline and at 4, 6, and 12 months after enrolment.
详细描述
Details will be included a protocol paper which will be submitted to an open-access journal.
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
- Single (Investigator)
盲法说明
Due to the nature of the intervention, blinding of participants, intervention providers, and outcome assessors will not be possible. However, statistical analyses and interpretation will be conducted without knowledge of group allocation.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 39 years of age
- •Are currently undergoing or have completed curative-intent cancer treatment within the past five years
- •Can understand and communicate in Danish and provide informed consent independently
- •Have been referred to municipal cancer rehabilitation services in the Municipality of Aarhus
排除标准
- •Diagnosed with cancer before the age of 18
- •Previously or currently receive rehabilitation
研究组 & 干预措施
YATAC programme
干预措施: YATAC programme (Behavioral)
Standard rehabilitation
干预措施: Standard rehabilitation (Behavioral)
结局指标
主要结局
Feasibility outcomes
时间窗: Baseline
1\) Recruitment rate: Number of participants included within the planned recruitment period (July 2026-June 2027). Data will be collected using screening and recruitment logs completed by a responsible contact professional from the Municipality of Aarhus.
Feasibility outcomes
时间窗: Up to 12 months after baseline
3\) Attrition rate: Proportion of participants who withdraw during the intervention period. Data about attrition will be collected using withdrawal registrations and participant records.
Feasibility outcomes
时间窗: Four months after baseline
4\) Adverse events: Frequency, type, and severity of intervention-related adverse events. and serious adverse events. Participants will be asked to self-report intervention-related adverse events and serious adverse events.
Feasibility outcomes
时间窗: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
6\) Assessment burden: Participant-reported burden and acceptability of assessments. Short evaluation survey completed after assessments using 5-point Likert.
Recruitment rate
时间窗: Baseline
1\) Recruitment rate: Number of participants included within the planned recruitment period (July 2026-June 2027). Data will be collected using screening and recruitment logs completed by a responsible contact professional from the Municipality of Aarhus.
Acceptability of randomisation
时间窗: Baseline
2\) Acceptability of randomisation: Proportion of randomised participants who accept allocation and commence their assigned study arm. A contact professional from the Municipality of Aarhus will complete data recruitment and allocation records.
Attrition rate
时间窗: Up to 12 months after baseline
3\) Attrition rate: Proportion of participants who withdraw during the intervention period. Data about attrition will be collected using withdrawal registrations and participant records.
Adverse events
时间窗: Four months after baseline
4\) Adverse events: Frequency, type, and severity of intervention-related adverse events. and serious adverse events. Participants will be asked to self-report intervention-related adverse events and serious adverse events.
Completeness of data
时间窗: Four months after baseline
5\) Completeness of data collection: Completion of primary patient-reported outcome at primary endpoint. Questionnaire completion logs will be used.
Assessment burden
时间窗: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
6\) Assessment burden: Participant-reported burden and acceptability of assessments. Short evaluation survey completed after assessments using 5-point Likert.
次要结局
- Outcomes(* Baseline * Four months after baseline * Six months after baseline * 12 months after baseline)
- Health-related quality of life(* Baseline * Four months after baseline * Six months after baseline * 12 months after baseline)
- AYA-specific quality of life(* Baseline * Four months after baseline * Six months after baseline * 12 months after baseline)
- Self-Efficacy(* Baseline * Four months after baseline * Six months after baseline * 12 months after baseline)