Feasibility of the YATAC Programme

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: A rehabilition programme for young adult cancer survivors

• Registration Number: NCT05551286
• Lead Sponsor: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-30
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Primary Completion: 2022-11-30
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Young Adults Taking Action	A rehabilition programme for young adult cancer survivors	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.

Primary Outcome Measures

Name	Time	Method
Acceptability; Affective attitude	10 weeks	The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.
Fidelity	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care; 🇩🇰 Nyborg, The Region Of Southern Denmark, Denmark