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Clinical Trials/NCT02719561
NCT02719561
Completed
Not Applicable

Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer

Anna Spathis0 sites20 target enrollmentJune 2016
ConditionsFatigue

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatigue
Sponsor
Anna Spathis
Enrollment
20
Primary Endpoint
Participant-reported feedback on design content as assessed via interviews
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer patients. Despite this, there has been virtually no research evaluating treatment for cancer-related fatigue in this young patient group. The investigators are undertaking a small qualitative study to co-design a fatigue intervention, that will then be evaluated in future research to assess its effectiveness.

Detailed Description

This small qualitative study will involve 7-10 patients who are within one year of completing cancer treatment, as well as some parents. Participants will be recruited from one centre, the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases will involve a) participants being interviewed individually and attending a focus group, b) patients receiving the prototype co-designed intervention, and c) participants being interviewed after the intervention to provide feedback to allow further refinement of the intervention. The intervention will be delivered by an Allied Health Professional in the setting that participants have chosen. It is likely to involve, at a minimum, education about fatigue and support with increasing activity. It will not include administration of any medication.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
February 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Anna Spathis
Responsible Party
Sponsor Investigator
Principal Investigator

Anna Spathis

Consultant in Palliative Medicine

Cambridge University Hospitals NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Aged 16-27 with a diagnosis of cancer
  • Currently or previously known to the Cambridge Teenage and Young Adult cancer service
  • Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.
  • A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month
  • Able to give informed consent
  • The parent of a patient participant or a patient who would be eligible to participate
  • The patient consents to the parent being approached about the study
  • The parent is able to give informed consent

Exclusion Criteria

  • Current participation in another clinical trial

Outcomes

Primary Outcomes

Participant-reported feedback on design content as assessed via interviews

Time Frame: 3 months

Participant-reported feedback on design acceptability as assessed via interviews

Time Frame: 3 months

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