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Recruiting Not applicable

Evaluating the YATAC Programme

NCT07692763 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-07-03
Last updated
2026-07-10

Condition(s) studied

CancerYoung Adults

Investigational drug(s) / intervention(s)

YATAC programmeStandard rehabilitation

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Folkesundhed (Public Health), the Municipality of Aarhus Aarhus Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07692763 on ClinicalTrials.gov ↗ ← All trials in Denmark