Folkesundhed (Public Health), the Municipality of Aarhus
Aarhus, 8000, Denmark
Location status: Recruiting
NCT Number: NCT07692763
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.
Interested in participating?
Request Info18 year–39 year
All sexes
Interventional
Not applicable
Aarhus, 8000, Denmark
Location status: Recruiting
Details will be included a protocol paper which will be submitted to an open-access journal.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Time frame: Baseline
Time frame: Up to 12 months after baseline
Time frame: Four months after baseline
Time frame: Four months after baseline
Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Time frame: * 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.
Time frame: * 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.
Time frame: * 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.
Time frame: Up to four months baseline
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.
Contact information is provided by the study sponsor or research team.
Marc Sampedro Pilegaard, PhD
CONTACT
Maria Aagesen, PhD
CONTACT
University of Aarhus
Other
The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults
Acronym: YATAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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