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

NCT ID: NCT02719561

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-02-28

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.

Conditions

Fatigue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fatigue Intervention

Intervention Type: BEHAVIORAL

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

Interventions

Fatigue Intervention

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anna Spathis

OTHER

Sponsor Role: lead

Responsible Party

Anna Spathis

Consultant in Palliative Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anna Spathis, MA MB BChir

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Other Identifiers

A093987

Identifier Type: -

Identifier Source: org_study_id