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

May 19, 2017 updated by: Anna Spathis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 27 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients:

  • 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

Parents:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fatigue intervention
Fatigue Intervention is to be co-designed by participants, and likely to include education, energy conservation and activity promotion. Participants will also decide the name of the Fatigue Intervention
Behavioral: Fatigue Intervention
The Fatigue Intervention will include education, energy conservation and activity promotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant-reported feedback on design content as assessed via interviews
Time Frame: 3 months
3 months
Participant-reported feedback on design acceptability as assessed via interviews
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Spathis

Investigators

  • Principal Investigator: Anna Spathis, MA MB BChir, Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A093987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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