FatigueNCT02719561
Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
A study testing Fatigue Intervention in people with Fatigue, run by Anna Spathis.
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. Read more about this study
- Who is it for?
- Ages 16 to 27 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Fatigue Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- Current participation in another clinical trial
About this study
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.
Read the 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
- Being tested
- Fatigue Intervention
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue InterventionBehavioural
The Fatigue Intervention will include education, energy conservation and activity promotion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Fatigue Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-reported feedback on design content as assessed via interviews
Measured: 3 months
Participant-reported feedback on design acceptability as assessed via interviews
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Spathis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Spathis, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Anna Spathis, MA MB BChir, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719561
- Sponsor's protocol ID
- A093987
- Status last verified
- May 2017
- First submitted
- 17 Mar 2016
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT02719561
- Acronym / sponsor ID
- A093987
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Anna SpathisUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue intervention | Experimental | Behavioral: Fatigue InterventionFatigue 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 |
Who may qualify
- Ages
- 16 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Current participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue InterventionThe Fatigue Intervention will include education, energy conservation and activity promotion | Behavioural | Fatigue intervention |
Primary outcome
Participant-reported feedback on design content as assessed via interviews
Time frame: 3 months
Participant-reported feedback on design acceptability as assessed via interviews
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Spathis, MA MB BChir principal investigator
Cambridge University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Intervention in people with Fatigue, run by Anna Spathis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported feedback on design content as assessed via interviews (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.