Feasibility of the YATAC Programme

Cancer Clinical Trial

— YATAC  

Official title:

The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551286
• Other study ID #: 1234
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 28, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care	Nyborg	The Region Of Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care	Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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