Evaluating the YATAC Programme

NCT07692763 | Recruiting DMC

• 4 other identifiers: Young Adult Taking ACtionR379-A2256323-20-0478R95-A4572
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Young Adults; Cancer

Keywords

Randomised controlled trial; Quality of life; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Up to 12 months after baseline

• 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.

  Four months after baseline

• Completeness of data

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

  Four months after baseline

• Assessment burden

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

  * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline

Secondary Outcomes (3)

• Health-related quality of life

  * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline

• AYA-specific quality of life

  * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline

• Self-Efficacy

  * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline

Other Outcomes (1)

• Embedded qualitative study

  Up to four months baseline

Study Arms (2)

YATAC programme

EXPERIMENTAL

Behavioral: YATAC programme

Standard rehabilitation

ACTIVE COMPARATOR

Behavioral: Standard rehabilitation

Interventions

YATAC programme BEHAVIORAL

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.

YATAC programme

Standard rehabilitation BEHAVIORAL

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

Standard rehabilitation

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with cancer before the age of 18
• Previously or currently receive rehabilitation

Sponsors & Collaborators

• University of Aarhus: lead
• Gødstrup Hospital: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Folkesundhed (Public Health), the Municipality of Aarhus

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marc Sampedro Pilegaard, PhD

  Social Medicine and Rehabilitation, Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Aagesen, PhD

CONTACT

004529723294; maagesen@health.sdu.dk

Marc Sampedro Pilegaard, PhD

CONTACT

004520722972; masamp@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 9, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: A protocol paper will be submitted in August 2026.
• Access Criteria: Open access.

Locations

DK (1)