- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807216
Evaluating Feasibility of the YATAC Programme (YATAC)
Feasibility Study Assessing Content and Delivery of the YATAC Programme
Between 2019 and 2023, the Young Adult Taking Action (YATAC) program was developed to support young adults recovering from cancer. The program is based on three key studies:
- A review of previous programs designed to help young adult cancer survivors.
- A study where young adults, their families and friends, and healthcare professionals shared what kind of support young people need to return to everyday life.
- A collaborative process where young adults, professionals, and researchers worked together to design the program's content and how it should be delivered.
YATAC is specifically designed for young adults and includes different areas of support, such as setting goals, managing daily life, staying active, coping with psychological challenges, navigating education and work, understanding rights and finances, relationships and sexuality, family and friends, and peer-to-peer support.
The first phase of the project was funded by the Danish Cancer Society, the Region of Southern Denmark, the University of Southern Denmark, and REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care.
One of the study in the second phase includes:
Study 1: A feasibility study to see if young adults find the program relevant and helpful, and whether they are able to participate. A total of 40 young adults will try the program at the Center for Cancer and Health in Copenhagen. The findings will help refine the program so it can be adapted to local healthcare services.
The results from these studies will provide valuable insights into how to better support young adult cancer survivors and reduce the long-term challenges they face. The program is expected to improve their quality of life while also helping to reduce healthcare costs and social inequality.
Study Overview
Detailed Description
Young adult cancer survivors aged 18-39 experience extensive age-specific late effects after cancer treatment affecting their everyday life; yet, they are not receiving rehabilitation after ending treatment, leading to reduced health-related quality of life (HRQoL).
In 2019, the 'Young Adult Taking Action' (YATAC) programme was established to develop a rehabilitation programme supporting young adult cancer survivors in taking control over their everyday life and increasing their HRQoL. The programme is a person-centred, goal-oriented, interdisciplinary and peer-based intervention. It is delivered over 16 weeks, primarily as a group-based intervention and consists of the following components:
- Needs assessment and goal setting
- Everyday life
- Physical activity
- Mental health
- Education and work
- Sexuality and relationship
- Family and friends
The overall perspectives are to improve quality of life, self-efficacy, functioning and reduce cancer and treatment-related late effects in young adult cancer survivors.
The programme has undergone a development process and is now ready to be tested to prepare national scalability.
The study include:
1) A feasibility study assessing the content and delivery of the YATAC programme for young adult cancer survivors in the Municipality of Copenhagen. Qualitative and quantitative data will be collected about acceptability of the programme and its intervention components, potential mechanisms of action, perceived value, benefits, harms, and unintended consequences and fidelity, reach, and dose. Furthermore, costs related to content and delivery of the YATAC programme will also be evaluated.
The project will potentially change rehabilitation practice in Danish municipalities for young adult cancer survivors and reduce the disabling late effects from cancer treatment, so they can obtain the best possible HRQoL.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen N, Denmark, 2200
- Center for Kræft og Sundhed
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København N
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Copenhagen, København N, Denmark, 2200
- Center for Kræft og Sundhed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Included participants will be between 18-39 years old with any cancer diagnosis,
- Undergoing or having undergone curative intended cancer treatment
- Reporting a rehabilitation need
- Speaking and understanding the Danish language
- Living in the Municipality of Copenhagen
Exclusion Criteria:
- Young people aged 18-39 who were diagnosed with cancer before the age of 18.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: YATAC
The programme draws on a person-centered approach and is designed to enhance the constructs of social cognitive theory, with an emphasis on self-efficacy .The programme comprises seven components, with several sessions providing knowledge, strategies, and practical exercises. The intervention starts with one mandatory component: 1) needs assessment and goal setting. These inform which, when, and how many sessions within the following components the participants will receive: 2. Everyday life 3. Physical activity 4. Psychological issues 5. Education and work 6. Sexuality and relationship 7. Family and friends The programme is delivered over 16 weeks, primarily as a group-based intervention. The components last 30-120 minutes and are provided by an interdisciplinary team at rehabilitation centers. |
Age-specific rehabilitation for young adult cancer survivors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative data
Time Frame: Qualitative will be collected during the 16 weeks of intervention, including baseline (T1), session delivery (T2), and the end of the 16 weeks (T3).
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Quantitative data from professionals delivering the programme: Paper-based forms will collect data about fidelity, dose, and the programme's overall value. Quantitative data from participants: They will report their perceived value of each session, the degree to which they could participate in each session, the overall value of the programme regarding improvement in everyday life and self-efficacy, and the degree to which they have adopted the content from the sessions into their everyday lives. Furthermore, the investigators will also evaluate the value of using peer-to-peer support. |
Qualitative will be collected during the 16 weeks of intervention, including baseline (T1), session delivery (T2), and the end of the 16 weeks (T3).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Qualitative data
Time Frame: End at 16 weeks
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Qualitative data from participants: A purposively selected sample of the participants will be invited to participate in a semi-structured focus group interview focusing on perceived benefits, harms, unintended consequences, and acceptability (n=10). Qualitative data from professionals: The professionals will be invited to a focus group interview on the same aspects as above. |
End at 16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Costs
Time Frame: Baseline, during delivery and end of programme at 16 weeks.
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Resource use associated with programme delivery will be tested to ensure high-quality measurements, enabling the following cost estimation for the intervention.
Moreover, a costing questionnaire registering background information, health service use and productivity loss will be tested among the participants to enable a future cost-effectiveness analysis of the YATAC programme.
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Baseline, during delivery and end of programme at 16 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20240101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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