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Clinical Trials/NCT05551286
NCT05551286
Completed
Not Applicable

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

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care1 site in 1 country19 target enrollmentAugust 30, 2022
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Enrollment
19
Locations
1
Primary Endpoint
Acceptability; Affective attitude
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2022
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Acceptability; Affective attitude

Time Frame: 10 weeks

The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.

Fidelity

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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