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Recruiting NCT07692763

Evaluating the YATAC Programme

No phase Interventional Cancer Young Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YATAC programme, Standard rehabilitation.
Who it may be relevant to
Registry conditions: Cancer, Young Adults. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults

Overview

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

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

Primary outcome measures

  • Recruitment rate [Time frame: Baseline]
  • Acceptability of randomisation [Time frame: Baseline]
  • Attrition rate [Time frame: Up to 12 months after baseline]
  • Adverse events [Time frame: Four months after baseline]
  • Completeness of data [Time frame: Four months after baseline]
  • Assessment burden [Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
Secondary outcome measures (3)
  • Health-related quality of life [Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
  • AYA-specific quality of life [Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]
  • Self-Efficacy [Time frame: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Folkesundhed (Public Health), the Municipality of Aarhus — Aarhus

Identifiers

NCT: NCT07692763 · Young Adult Taking ACtion · R379-A22563 · 23-20-0478 · R95-A4572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗