Evaluating the YATAC Programme (YATAC)

Aktív összehasonlító: Standard rehabilitation

Viselkedési: Standard rehabilitation

Participants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise.

Kísérleti: YATAC programme

Viselkedési: YATAC programme

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.

Recruitment 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.

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.

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.

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.

Completeness of data

5) Completeness of data collection: Completion of primary patient-reported outcome at primary endpoint. Questionnaire completion logs will be used.

Assessment burden

6) Assessment burden: Participant-reported burden and acceptability of assessments. Short evaluation survey completed after assessments using 5-point Likert.

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.

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.

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.

Embedded qualitative study

An embedded qualitative study will be conducted alongside the pilot RCT to explore barriers and facilitators related to recruitment, participation, retention, and acceptability of participation in rehabilitation intervention trials among young adults with cancer.