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Completed

NCT Number: NCT05551286

Feasibility of the YATAC Programme

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Nyborg, The Region of Southern Denmark, 5800, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A rehabilition programme for young adult cancer survivors

Other

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.

Primary outcomes

  1. Acceptability; Affective attitude

    Time frame: 10 weeks

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Other

Collaborators

  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: YATAC

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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