CancerYATACNCT07692763
Evaluating the YATAC Programme
A study testing YATAC programme and Standard rehabilitation in people with Cancer and Young Adults, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Young Adults
- What is being tested?
- YATAC programme and Standard rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with cancer before the age of 18
- Previously or currently receive rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Folkesundhed (Public Health), the Municipality of Aarhus
Aarhus, 8000
Tenna Askjær, Physioterapist and MSc, 004541859049, tea@aarhus.dk
About this study
Official title: The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults
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.
Read the detailed description
Details will be included a protocol paper which will be submitted to an open-access journal.
- Conditions
- Cancer, Young Adults
- Being tested
- YATAC programme, Standard rehabilitation
- Keywords
- Randomised controlled trial, Quality of life, Rehabilitation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YATAC programmeBehavioural
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 rehabilitationBehavioural
Participants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise.
| Study group | Role | What they receive |
|---|---|---|
| YATAC programme | Experimental | Not described Receives: Behavioral: YATAC programme |
| Standard rehabilitation | Active comparator | Not described Receives: Behavioral: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
- 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.
Measured: Baseline
Acceptability of randomisation
- 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.
Measured: Baseline
Attrition rate
- Attrition rate: Proportion of participants who withdraw during the intervention period. Data about attrition will be collected using withdrawal registrations and participant records.
Measured: Up to 12 months after baseline
Adverse events
- 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.
Measured: Four months after baseline
Completeness of data
- Completeness of data collection: Completion of primary patient-reported outcome at primary endpoint. Questionnaire completion logs will be used.
Measured: Four months after baseline
Assessment burden
- Assessment burden: Participant-reported burden and acceptability of assessments. Short evaluation survey completed after assessments using 5-point Likert.
Measured: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Secondary outcomes (3)
Health-related quality of life
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.
Measured: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
AYA-specific quality of life
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.
Measured: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Self-Efficacy
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.
Measured: * Baseline * Four months after baseline * Six months after baseline * 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start3 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Gødstrup Hospital
- Responsible party
- Sponsor
- Investigators
- Marc Sampedro Pilegaard, PhD, Principal investigator, Social Medicine and Rehabilitation, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692763
- Sponsor's protocol ID
- Young Adult Taking ACtion
- Other IDs
- R379-A22563, 23-20-0478, R95-A4572
- Acronym
- YATAC
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Details will be published in an open-access journal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults
- ClinicalTrials.gov ID
- NCT07692763
- Acronym / sponsor ID
- YATAC / Young Adult Taking ACtion
- Conditions
- Cancer, Young Adults
- Keywords
- Randomised controlled trial, Quality of life, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Gødstrup Hospital
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| YATAC programme | Experimental | Behavioral: YATAC programme |
| Standard rehabilitation | Active comparator | Behavioral: Standard rehabilitation |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with cancer before the age of 18
- Previously or currently receive rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YATAC programmeThe 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. | Behavioural | YATAC programme |
| Standard rehabilitationParticipants assigned to the control group will receive the standard cancer rehabilitation programme offered through Folkesundhed Aarhus. This includes physical exercise. | Behavioural | Standard rehabilitation |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: * 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Details will be published in an open-access journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Sampedro Pilegaard, PhD principal investigator
Social Medicine and Rehabilitation, Gødstrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YATAC programme and Standard rehabilitation in people with Cancer and Young Adults, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Aagesen, PhD (004529723294, maagesen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.