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.
Details will be included a protocol paper which will be submitted to an open-access journal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
50
The YATAC 2.0 intervention will consist of a 16-week multidimensional rehabilitation programme including a mandatory needs assessment and goal-setting component, which will determine the primarily group-based components in which the young adults will participate. These components will include: 1) Physical activity, 2) Fatigue, sleep, and cognitive challenges, 3) Mental health, 4) Sexuality and relationships, 5) Family and friends, 6) Nutrition, and 7) Education and work. Each participant will be assigned a designated contact person, either a nurse or physiotherapist, who will follow the young adult throughout the programme. The contact person will conduct the needs assessments and goal-setting consultations and contribute to selected group sessions. In addition, one of the contact persons will be present during group-based sessions alongside the primary facilitator to promote continuity, coordination, and a sense of safety throughout the rehabilitation trajectory.
Participants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise.
Folkesundhed (Public Health), the Municipality of Aarhus
Aarhus, Denmark
RECRUITINGRecruitment rate
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.
Time frame: Baseline
Acceptability of randomisation
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.
Time frame: Baseline
Attrition rate
3\) Attrition rate: Proportion of participants who withdraw during the intervention period. Data about attrition will be collected using withdrawal registrations and participant records.
Time frame: Up to 12 months after baseline
Adverse events
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.
Time frame: Four months after baseline
Completeness of data
5\) Completeness of data collection: Completion of primary patient-reported outcome at primary endpoint. Questionnaire completion logs will be used.
Time frame: Four months after baseline
Assessment burden
6\) Assessment burden: Participant-reported burden and acceptability of assessments. Short evaluation survey completed after assessments using 5-point Likert.
Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Health-related quality of life
Improvements of the YATAC programme will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a cancer-specific and internationally validated instrument consisting of 30 items across 15 domains, including five functional scales, three symptom scales, six single symptom items, and a global health status/quality of life scale. Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores on functional and global health status scales indicate better functioning and HRQoL, whereas higher symptom scores indicate greater symptom burden. The primary endpoint of the intervention will be global health status/quality of life four months after baseline. The remaining outcomes from the EORTC QLQ-C30 include: physical, role, emotional, cognitive, and social functioning; fatigue; pain; dyspnoea; and insomnia.
Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
AYA-specific quality of life
Improvements of the YATAC programme will also be evaluated using the AYA-specific quality of life questionnaire, which is a supplementary module in the EORTC QLQ-AYA30 developed for adolescents and young adults with cancer aged 14-39 years. The questionnaire includes five multi-item scales assessing: 1) Activity limitations, 2) Worry about cancer and the future, 3) Self-esteem, 4) Relationships, and 5) Positive changes. In addition, nine single items address domains such as work/education, romantic and sexual life, relocation, caregiving responsibilities, and diet restrictions. Scores are transformed to a 0-100 scale, where higher scores reflect greater symptom burden, except for positive changes, where higher scores indicate better functioning The outcomes from EORTC QLQ-A include: Activity limitations, worry about cancer and the future, self-esteem, relationships, positive changes, and work/education, romantic and sexual life, relocation.
Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Self-Efficacy
Improvements of the YATAC programme will also be evaluated using the Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G) consisting of six items rated on a 10-point Likert scale ranging from 1 ("not at all confident") to 10 ("totally confident"). The mean score across items represents the overall self-efficacy score, with higher scores indicating greater confidence in managing health-related challenges.
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Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline