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

Primary Purpose

Fatigue

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Fatigue Intervention

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

16 Years - 27 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fatigue intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Participant-reported feedback on design content as assessed via interviews

Participant-reported feedback on design acceptability as assessed via interviews

Secondary Outcome Measures

Full Information

NCT ID

NCT02719561

First Posted

March 17, 2016

Last Updated

May 19, 2017

Sponsor

Anna Spathis

1. Study Identification

Unique Protocol Identification Number

NCT02719561

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anna Spathis

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fatigue intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Fatigue Intervention

Intervention Description

The Fatigue Intervention will include education, energy conservation and activity promotion

Primary Outcome Measure Information:

Title

Participant-reported feedback on design content as assessed via interviews

Time Frame

3 months

Title

Participant-reported feedback on design acceptability as assessed via interviews

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

27 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Spathis, MA MB BChir

Organizational Affiliation

Cambridge University Hospitals NHS Foundation Trust

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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