Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 6:03 PM
Study NCT ID:
NCT02801734
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year'}, {'measure': 'Number of participants who died at home', 'timeFrame': '1 year'}, {'measure': 'Number of participants with anti-cancer therapy in the last 4 weeks of life', 'timeFrame': 'Last four weeks of life'}], 'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '4 weeks', 'description': 'Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.'}, {'measure': 'Quality of life', 'timeFrame': '8 weeks', 'description': 'Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.'}, {'measure': 'Quality of life', 'timeFrame': '12 weeks', 'description': 'Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.'}, {'measure': 'Psychological distress', 'timeFrame': '4 weeks', 'description': 'Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).'}, {'measure': 'Psychological distress', 'timeFrame': '8 weeks', 'description': 'Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).'}, {'measure': 'Psychological distress', 'timeFrame': '12 weeks', 'description': 'Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with referral to palliative care services', 'timeFrame': '6 months'}, {'measure': 'Number of hospital admissions', 'timeFrame': '6 months'}, {'measure': 'Number of visits to the emergency department', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Lung Cancer']}, 'descriptionModule': {'briefSummary': 'i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).\n\nii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.\n\niii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.\n\nAll participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.\n\nA total sample of 60 patients (30 in each arm) will be recruited.\n\nClinical Significance\n\nIf successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Has stage 3 or 4 lung cancer\n* ECOG 0,1 or 2\n* Able and willing to participate in the EQUIP programme\n\nExclusion criteria\n\n\\- Unable to communicate in English or Mandarin'}, 'identificationModule': {'nctId': 'NCT02801734', 'acronym': 'EQUIP', 'briefTitle': 'Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer', 'orgStudyIdInfo': {'id': 'NCCSPG-YR2016-JAN-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in the EQUIP intervention group will individually receive four face-to-face sessions with a palliative care nurse.\n\nFor all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.', 'interventionNames': ['Other: EQUIP']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.'}], 'interventions': [{'name': 'EQUIP', 'type': 'OTHER', 'description': 'Patients in the EQUIP intervention group will receive four face-to-face sessions. The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke-NUS Graduate Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}