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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719561
• Other study ID #: A093987
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: May 19, 2017
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anna Spathis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant-reported feedback on design content as assessed via interviews		3 months
Primary	Participant-reported feedback on design acceptability as assessed via interviews		3 months