Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT04900935
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-centered, Optimal Integration of Survivorship and Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking of participants and care providers is not possible in this clinical intervention. However, we will mask the outcomes assessor to minimize bias.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two phases of this research study: 1) an open pilot of 10 patients to refine the intervention and study protocol, in which all patients receive the POISE intervention; followed by 2) a randomized controlled trial in which patients are randomized to receive either the POISE intervention or usual care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Uncertainty tolerance', 'timeFrame': '12 weeks', 'description': 'Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.'}, {'measure': 'Uncertainty tolerance', 'timeFrame': '20 weeks', 'description': 'Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.'}, {'measure': 'Psychological Distress', 'timeFrame': '12 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.'}, {'measure': 'Psychological Distress', 'timeFrame': '20 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.'}, {'measure': 'Multidimensional quality of life', 'timeFrame': '12 weeks', 'description': 'Functional Assessment of Cancer Therapy-Lung, a quality of life measure'}, {'measure': 'Multidimensional quality of life', 'timeFrame': '20 weeks', 'description': 'Functional Assessment of Cancer Therapy-Lung, a quality of life measure'}, {'measure': 'Hope and goal setting', 'timeFrame': '12 weeks', 'description': 'Adult Trait Hope Scale'}, {'measure': 'Hope and goal setting', 'timeFrame': '20 weeks', 'description': 'Adult Trait Hope Scale'}], 'primaryOutcomes': [{'measure': 'Feasibility of POISE - enrollment', 'timeFrame': '20 weeks', 'description': '≥60% enrollment among eligible patientsamong patients in the POISE group'}, {'measure': 'Feasibility of POISE - completion of all sessions among patients in intervention group', 'timeFrame': '20 weeks', 'description': '≥70% completion of all sessions in the intervention arm'}, {'measure': 'Feasibility of POISE - completion of surveys in both arms', 'timeFrame': '20 weeks', 'description': '≥70% completion of all surveys in both arms'}], 'secondaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '20 Weeks', 'description': '4-item measure of satisfaction and comfort with the intervention'}, {'measure': 'Emotional coping with prognosis and prognostic awareness', 'timeFrame': '12 weeks', 'description': 'Subscale of Prognostic Awareness Impact Scale'}, {'measure': 'Emotional coping with prognosis and prognostic awareness', 'timeFrame': '20 weeks', 'description': 'Subscale of Prognostic Awareness Impact Scale'}, {'measure': 'Self efficacy', 'timeFrame': '12 weeks', 'description': 'Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale, ranging from 1 (not at all confident) to 10 (totally confident).'}, {'measure': 'Self efficacy', 'timeFrame': '20 weeks', 'description': 'Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale'}, {'measure': 'Documentation of Goals and Values', 'timeFrame': '20 weeks', 'description': 'The investigators will apply a previously developed natural language processing/machine learning (ML) algorithm to palliative care and oncology notes from the study period in order to identify goals of care conversations using an inductive supervised ML classifier. Notes with a predicted probability of greater than 0.5 will be classified as containing goals of care documentation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stage IV Non-small Cell Lung Cancer', 'Targeted Therapy', 'Nonsmall Cell Lung Cancer', 'Carcinoma, Non-Small-Cell Lung', 'ALK-positive Non-small Cell Lung Cancer', 'EGFR Positive Non-small Cell Lung Cancer', 'ROS1 Positive Non-Small Cell Lung Cancer', 'Palliative care', 'survivorship', 'RET Fusion positive Non-Small Cell Lung Cancer'], 'conditions': ['Stage IV Non-small Cell Lung Cancer', 'Targeted Therapy', 'Nonsmall Cell Lung Cancer', 'Carcinoma, Non-Small-Cell Lung', 'ALK-positive Non-small Cell Lung Cancer', 'EGFR Positive Non-small Cell Lung Cancer', 'Palliative Care', 'Survivorship']}, 'referencesModule': {'references': [{'pmid': '40812801', 'type': 'BACKGROUND', 'citation': 'Richard HA, Sarathy R, Rabideau DJ, Feldman J, Cartagena L, Patel H, Sequist LV, Park E, Jackson V, Greer JA, Temel JS, Petrillo LA. Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Aug 13;15(8):e098075. doi: 10.1136/bmjopen-2024-098075.'}], 'seeAlsoLinks': [{'url': 'https://bmjopen.bmj.com/content/bmjopen/15/8/e098075.full.pdf', 'label': 'Protocol paper'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are\n\n* is POISE feasible to deliver and acceptable to patients\n* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.', 'detailedDescription': 'This research study involves an intervention consisting of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with NSCLC.\n\nThe research study procedures include:\n\n* Four 60-minute visits with a trained palliative care clinician\n* Questionnaires and an exit interview\n* Chart Review\n\nIt is expected that about 70 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study: 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* MGH Cancer Center patient\n* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)\n* Receiving targeted therapy\n* Ability to respond in English or Spanish\n\nExclusion Criteria:\n\n* Cognitive impairment or serious mental illness that limits ability to provide informed consent\n* Need for urgent palliative care or hospice referral\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT04900935', 'briefTitle': 'Patient-centered, Optimal Integration of Survivorship and Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Patient-centered, Optimal Integration of Survivorship and Palliative Care', 'orgStudyIdInfo': {'id': '20-722'}, 'secondaryIdInfos': [{'id': 'K08CA263549', 'link': 'https://reporter.nih.gov/quickSearch/K08CA263549', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POISE', 'description': 'The intervention will be a structured palliative care intervention in which patients will meet with a palliative care clinician who has been trained on a manual with specific topics to be covered in each of the four visits:\n\n* Three surveys: baseline, 12-week, and 20-week post-enrollment\n* Four 60-minute visits with a trained palliative care clinician\n* Semi-structured exit interview\n* Chart review', 'interventionNames': ['Behavioral: POISE']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.'}], 'interventions': [{'name': 'POISE', 'type': 'BEHAVIORAL', 'otherNames': ['palliative care intervention'], 'description': 'POISE (Patient-centered, Optimal Integration of Survivorship and palliative carE) is a brief, population-specific intervention that consists of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with long, uncertain cancer trajectories.', 'armGroupLabels': ['POISE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura A. Petrillo, MD', 'role': 'CONTACT', 'email': 'lpetrillo2@mgh.harvard.edu', 'phone': '617-724-4000'}, {'name': 'Laura A. Petrillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Laura A Petrillo, MD', 'role': 'CONTACT', 'email': 'lpetrillo2@mgh.harvard.edu', 'phone': '(617) 724-4000'}], 'overallOfficials': [{'name': 'Laura A Petrillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Laura Petrillo, M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}