Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-02 @ 3:33 AM
Study NCT ID:
NCT02719561
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant-reported feedback on design content as assessed via interviews', 'timeFrame': '3 months'}, {'measure': 'Participant-reported feedback on design acceptability as assessed via interviews', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '27 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Aged 16-27 with a diagnosis of cancer\n* Currently or previously known to the Cambridge Teenage and Young Adult cancer service\n* Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.\n* A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month\n* Able to give informed consent\n\nParents:\n\n* The parent of a patient participant or a patient who would be eligible to participate\n* The patient consents to the parent being approached about the study\n* The parent is able to give informed consent\n\nExclusion Criteria:\n\n* Current participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02719561', 'briefTitle': 'Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer', 'orgStudyIdInfo': {'id': 'A093987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fatigue intervention', 'description': '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', 'interventionNames': ['Behavioral: Fatigue Intervention']}], 'interventions': [{'name': 'Fatigue Intervention', 'type': 'BEHAVIORAL', 'description': 'The Fatigue Intervention will include education, energy conservation and activity promotion', 'armGroupLabels': ['Fatigue intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anna Spathis, MA MB BChir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Spathis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant in Palliative Medicine', 'investigatorFullName': 'Anna Spathis', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}