CancerYATACNCT05551286
Feasibility of the YATAC Programme
A study testing A rehabilition programme for young adult cancer survivors in people with Cancer, run by REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care at 1 site in Denmark.
Trial summary
Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- A rehabilition programme for young adult cancer survivors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Aug 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Being between 18-39 years old at baseline
- Have had any type of cancer
- Have completed primary/active cancer directed treatment (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention, while current hormonal treatments or maintenance therapies are permissible)
- Determined a need for rehabilitation determined by the REHPA scale (a linear analogue scale, where the participants indicate how close they are to living the life they desire after ending cancer treatment). The scale ranges from 0= 'goal reached' to 9= 'infinitely far from'
- Have access to a device with Internet options (i.e., smartphone or tablet)
Who cannot join
- Dependent in basic personal activities of daily living (personal care, dressing and eating)
- No permanent residence in Denmark
- Not able to speak and understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Nyborg, The Region of Southern Denmark, 5800
About this study
Official title: The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery
Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to increase participation in everyday life and improve health-related quality of life. The development of the intervention is guided by the British Medical Research Council's guidance (MRC) and the framework for the co-production and prototyping of public health interventions by Hawkins et al.
The present study will investigate the acceptability and fidelity of the intervention at the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the results of the study will be used to revise version 1.0 of the programme.
- Conditions
- Cancer
- Being tested
- A rehabilition programme for young adult cancer survivors
- Keywords
- Rehabilitation, Young adults
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A rehabilition programme for young adult cancer survivorsOther
The programme consists of 22 sessions focusing on; 1) everyday life (energy conservation, cognitive challenges, fatigue); 2) Physical activity; 3) psychological issues; 4) work and study d; 5) sexuality and relationship; 7) rights and finance, and 8) goal setting. The sessions include both education, workshops, and engagement in different activities and will be delivered by a multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults Taking Action | Experimental | The programme is person-centered, goal-oriented, and peer-based and is structured around a 5-day residential stay, an online follow-up after five weeks and a 2-day residential follow-up stay after ten weeks. Receives: Other: A rehabilition programme for young adult cancer survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability; Affective attitude
The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.
Measured: 10 weeks
Fidelity
Defined as the consistency of whether the intervention was implemented as intended. The professionals register to what extent they have implemented the session as intended on a 5-point Likert scale. Scores between 0-5, with higher scores indicating higher consistency.
Measured: 10 weeks
Dose
Defined as the quantity of intervention implemented. The professionals will report the number of elements implemented and the time used. In addition, the professional will give information on reasons for deviation from the manual.
Measured: 10 weeks
Adaptions
Defined as any adjustments made to the intervention. The professionals register and describe any adaptions they make and the reasons for this.
Measured: 10 weeks
Acceptability; burden
The participants perceived amount of effort required to participate. Scores between 0-5, with higher scores indicating high degree of effort.
Measured: 10 weeks
Acceptability; Ethicality
The participants opinion about the intervention's fit with their individuals value system. Scores between 0-5, with higher scores indicating higher consistency with value system.
Measured: 10 weeks
Acceptability; intervention cohesion
The participants understanding of the intervention and how it works. Scores between 0-5, with higher scores indicating higher understanding of the intervention.
Measured: 10 weeks
Acceptability; opportunity costs
The participants experience of opportunity costs, like benefits, values, or profits that must be given up to engage in the intervention. Scores between 0-5, with higher scores indicating higher degree of giving up on opportunity costs, like benefits, values, or profits.
Measured: 10 weeks
Acceptability; Perceived effectiveness
The participants experience of perceived effectiveness of the intervention. Scores between 0-5, with higher scores indicating higher degree of perceived effectiveness of the intervention.
Measured: 10 weeks
Acceptability; Self-efficacy
The participants confidence that they can perform the behavior(s) required to participate in the intervention. Scores between 0-5, with higher scores indicating higher confidence that they can perform the behavior(s) required to participate in the intervention.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start30 Aug 2022
- Primary completion30 Nov 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Maria Aagesen, PhD student, Principal investigator, The University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551286
- Sponsor's protocol ID
- 1234
- Acronym
- YATAC
- Status last verified
- Mar 2023
- First submitted
- 8 Sep 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aagesen M, Pilegaard MS, Ipsen KH, Jorgesen DS, Hauken MA, la Cour K. Program Delivery and Change in Patient-Reported Outcomes of an Age-Specific Rehabilitation Program for Young Adult Cancer Survivors: A Feasibility Study. J Adolesc Young Adult Oncol. 2026 Apr;15(2):124-133. doi: 10.1177/21565333251372461. Epub 2025 Dec 11.
PubMed 40903076
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery
- ClinicalTrials.gov ID
- NCT05551286
- Acronym / sponsor ID
- YATAC / 1234
- Conditions
- Cancer
- Keywords
- Rehabilitation, Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative CareUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 Sep 2022 (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 adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to increase participation in everyday life and improve health-related quality of life. The development of the intervention is guided by the British Medical Research Council's guidance (MRC) and the framework for the co-production and prototyping of public health interventions by Hawkins et al.
The present study will investigate the acceptability and fidelity of the intervention at the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the results of the study will be used to revise version 1.0 of the programme.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Adults Taking Action | Experimental | Other: A rehabilition programme for young adult cancer survivorsThe programme is person-centered, goal-oriented, and peer-based and is structured around a 5-day residential stay, an online follow-up after five weeks and a 2-day residential follow-up stay after ten weeks. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 18-39 years old at baseline
- Have had any type of cancer
- Have completed primary/active cancer directed treatment (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention, while current hormonal treatments or maintenance therapies are permissible)
- Determined a need for rehabilitation determined by the REHPA scale (a linear analogue scale, where the participants indicate how close they are to living the life they desire after ending cancer treatment). The scale ranges from 0= 'goal reached' to 9= 'infinitely far from'
- Have access to a device with Internet options (i.e., smartphone or tablet)
Key exclusion criteria (3 listed)
- Dependent in basic personal activities of daily living (personal care, dressing and eating)
- No permanent residence in Denmark
- Not able to speak and understand Danish
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 |
|---|---|---|
| A rehabilition programme for young adult cancer survivorsThe programme consists of 22 sessions focusing on; 1) everyday life (energy conservation, cognitive challenges, fatigue); 2) Physical activity; 3) psychological issues; 4) work and study d; 5) sexuality and relationship; 7) rights and finance, and 8) goal setting. The sessions include both education, workshops, and engagement in different activities and will be delivered by a multidisciplinary team. | Other | Young Adults Taking Action |
Primary outcome
Acceptability; Affective attitude
Time frame: 10 weeks
The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.
Fidelity
Time frame: 10 weeks
Defined as the consistency of whether the intervention was implemented as intended. The professionals register to what extent they have implemented the session as intended on a 5-point Likert scale. Scores between 0-5, with higher scores indicating higher consistency.
Dose
Time frame: 10 weeks
Defined as the quantity of intervention implemented. The professionals will report the number of elements implemented and the time used. In addition, the professional will give information on reasons for deviation from the manual.
Adaptions
Time frame: 10 weeks
Defined as any adjustments made to the intervention. The professionals register and describe any adaptions they make and the reasons for this.
Acceptability; burden
Time frame: 10 weeks
The participants perceived amount of effort required to participate. Scores between 0-5, with higher scores indicating high degree of effort.
Acceptability; Ethicality
Time frame: 10 weeks
The participants opinion about the intervention's fit with their individuals value system. Scores between 0-5, with higher scores indicating higher consistency with value system.
Acceptability; intervention cohesion
Time frame: 10 weeks
The participants understanding of the intervention and how it works. Scores between 0-5, with higher scores indicating higher understanding of the intervention.
Acceptability; opportunity costs
Time frame: 10 weeks
The participants experience of opportunity costs, like benefits, values, or profits that must be given up to engage in the intervention. Scores between 0-5, with higher scores indicating higher degree of giving up on opportunity costs, like benefits, values, or profits.
Acceptability; Perceived effectiveness
Time frame: 10 weeks
The participants experience of perceived effectiveness of the intervention. Scores between 0-5, with higher scores indicating higher degree of perceived effectiveness of the intervention.
Acceptability; Self-efficacy
Time frame: 10 weeks
The participants confidence that they can perform the behavior(s) required to participate in the intervention. Scores between 0-5, with higher scores indicating higher confidence that they can perform the behavior(s) required to participate in the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 40903076Aagesen M, Pilegaard MS, Ipsen KH, Jorgesen DS, Hauken MA, la Cour K. Program Delivery and Change in Patient-Reported Outcomes of an Age-Specific Rehabilitation Program for Young Adult Cancer Survivors: A Feasibility Study. J Adolesc Young Adult Oncol. 2026 Apr;15(2):124-133. doi: 10.1177/21565333251372461. Epub 2025 Dec 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maria Aagesen, PhD student principal investigator
The University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A rehabilition programme for young adult cancer survivors in people with Cancer, run by REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability; Affective attitude (time frame: 10 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551286, which also lists 1 linked publication.
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 29 Mar 2023.