NCT05551286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

September 8, 2022

Last Update Submit

March 28, 2023

Conditions

Cancer

Keywords

RehabilitationYoung adults

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (1)

Young Adults Taking Action

EXPERIMENTAL

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

Interventions

A rehabilition programme for young adult cancer survivorsOTHER

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.

Young Adults Taking Action

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Nyborg, The Region of Southern Denmark, 5800, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Maria Aagesen, PhD student

    The University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 22, 2022

Study Start

August 30, 2022

Primary Completion

November 30, 2022

Study Completion

February 28, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)