Clinical trial NCT05551286: Feasibility of the YATAC Programme
Official title: The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Rehabilitation
Young adults
Lead sponsor: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Southern Denmark
First posted: 2022-09-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability; Affective attitude
timeFrame: 10 weeks
measure: Fidelity
timeFrame: 10 weeks
measure: Dose
timeFrame: 10 weeks
measure: Adaptions
timeFrame: 10 weeks
measure: Acceptability; burden
timeFrame: 10 weeks
measure: Acceptability; Ethicality
timeFrame: 10 weeks
measure: Acceptability; intervention cohesion
timeFrame: 10 weeks
measure: Acceptability; opportunity costs
timeFrame: 10 weeks
measure: Acceptability; Perceived effectiveness
timeFrame: 10 weeks
measure: Acceptability; Self-efficacy
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
state: The Region Of Southern Denmark
Study officials:
affiliation: The University of Southern Denmark
name: Maria Aagesen, PhD student
role: PRINCIPAL_INVESTIGATOR
References: