Cancer, Young Adults
Conditions
Keywords
Randomised controlled trial, Quality of life, Rehabilitation
Brief summary
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.
Detailed description
Details will be included a protocol paper which will be submitted to an open-access journal.
Interventions
BEHAVIORALYATAC 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.
BEHAVIORALStandard rehabilitation
Participants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise.
Sponsors
University of Aarhus
University of Southern Denmark
Gødstrup Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Diagnosed with cancer before the age of 18 * Previously or currently receive rehabilitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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 | 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 | 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 | 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 | 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 | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline | 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 | * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline | 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 | * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline | 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. |
Countries
Denmark
Contacts
CONTACTMaria Aagesen, PhD
CONTACTMarc Sampedro Pilegaard, PhD
PRINCIPAL_INVESTIGATORMarc Sampedro Pilegaard, PhD
Social Medicine and Rehabilitation, Gødstrup Hospital
Outcome results
None listed