Feasibility of the YATAC Programme (YATAC)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: A rehabilition programme for young adult cancer survivors

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • The Region Of Southern Denmark
    • Nyborg, The Region Of Southern Denmark, Denmark, 5800
      • REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Young Adults Taking Action; 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.

Other: A rehabilition programme for young adult cancer survivors; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability; Affective attitude	The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.	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.	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.	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.	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.	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.	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.	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.	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.	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.	10 weeks

Collaborators and Investigators

• Sponsor: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
• Collaborators: University of Southern Denmark; Region of Southern Denmark
• Investigators: Principal Investigator: Maria Aagesen, PhD student, The University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Young adults
• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No