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

Sponsor

Anna Spathis (Other)

Overall Status

Completed

CT.gov ID

NCT02719561

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Behavioral: Fatigue Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Participant-reported feedback on design content as assessed via interviews [3 months]
Participant-reported feedback on design acceptability as assessed via interviews [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 27 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Anna Spathis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Spathis, Consultant in Palliative Medicine, Cambridge University Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02719561

Other Study ID Numbers:

A093987

First Posted:

Mar 25, 2016

Last Update Posted:

May 22, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of May 22, 2017