NCT02719561

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

March 17, 2016

Last Update Submit

May 19, 2017

Conditions

Fatigue

Outcome Measures

Primary Outcomes (2)

  • Participant-reported feedback on design content as assessed via interviews

    3 months

  • Participant-reported feedback on design acceptability as assessed via interviews

    3 months

Study Arms (1)

Fatigue intervention

EXPERIMENTAL

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

Interventions

Fatigue InterventionBEHAVIORAL

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

Fatigue intervention

Eligibility Criteria

Age16 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Current participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Spathis, MA MB BChir

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant in Palliative Medicine

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 25, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share