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

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: Fatigue
• Intervention / Treatment: Behavioral: Fatigue Intervention

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

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

Study record dates

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: Fatigue
• Other Study ID Numbers: A093987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO