Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04989556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Technology-Enhanced Palliative Care for Advanced Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D000070659', 'term': 'Patient Comfort'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-22', 'size': 195038, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-23T15:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in global distress score (GDS)', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Will consist of paired t-tests for the global distress score (GDS, calculated as a sum of 9 physical and psychosocial ESAS items, scored from 0-90 in which a range over 35 indicates high distress) between baseline and 2 weeks if the Edmonton Symptom Assessment Scale (ESAS) scores are approximately normally distributed. If the data are clearly not normally distributed will conduct Wilcoxon signed rank tests.'}], 'secondaryOutcomes': [{'measure': 'Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).', 'timeFrame': 'At 6 months after enrollment', 'description': 'We will measure incremental change in the scores of patient satisfaction using FAMCARE-P13 from the baseline values.\n\nWe also will measure the change in the scores every 4 weeks from the baseline score at time-point T0 to the 12 study weeks: weeks 4 (T4), 8 (T8), and 12 (T12). We will additionally measure at 6 months after enrollment.'}, {'measure': 'Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).', 'timeFrame': 'At 6 months after enrollment', 'description': 'We will measure incremental change in the scores for GDS using ESAS, a validated score of overall symptom intensity and burden derived from the ESAS. The GDS (range 0-90) is comprised of 9 symptoms: (1) the six physical ESAS symptoms (pain, fatigue, nausea, drowsiness, appetite, shortness of breath), (2) the two psychosocial symptoms (depression, anxiety), and (3) overall sense of wellbeing..\n\nWe also will measure the change in the scores every 4 weeks from the baseline score at time-point T0 to the 12 study weeks: weeks 4 (T4), 8 (T8), and 12 (T12). We will additionally measure at 6 months after enrollment.'}, {'measure': "Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention", 'timeFrame': 'Up to 12 weeks on phase I trial', 'description': "We will use semi-structured interviews with patients and caregivers to assess patients and caregivers' perceptions of TEC to understand the value of PC provider-initiated contact between clinic visits"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial investigates technology-enhanced palliative care for patients in phase I trials with cancer that has spread to other places in the body (advanced). The goal of this study is to learn if the technology-enhanced palliative care symptom-monitoring program, when combined with in-person clinic visits and standard remote care visits (by phone or video call), helps increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To assess the effect size of each palliative care intervention technology-enhanced palliative care, standard palliative care \\[SPC\\]) on the symptom burden of patients prior to or while on a phase I trial.\n\nSECONDARY OBJECTIVES:\n\nI To estimate the effect size of each palliative care intervention (TEC, SPC) on symptom burden over a 12-week period of a phase I trial.\n\nII. To estimate the effect size of each palliative care intervention (TEC, SPC) on clinical outcomes at 6 months post-enrollment.\n\nIII. To qualitatively assess patients' and caregivers' perceptions of receiving each TEC-based palliative care (PC) Intervention.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM I: Patients receive standard symptom management by palliative care team once every 4 weeks for 12 weeks. Patients and caregivers also may participate in an interview with supportive care nurse over 30-45 minutes during week 8.\n\nARM II: Patients in Phase I immunotherapy trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact every week. Patients and caregivers may participate in an interview with supportive care nurse over 330-45 minutes during week 8.\n\nARM III: Patients in Phase I non-immunotherapy clinical trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact once a week. In all 3 arms, follow-up communication will occur as deemed necessary by the PC team. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENT: Diagnosis of advanced solid tumor\n* PATIENT: Oncologic plan for a phase I trial\n* PATIENT: High symptom burden (defined as a score of \\>= 4 on at least 1 Edmonton Symptom Assessment Scale \\[ESAS\\] symptom, AND a global distress score \\[GDS\\] of \\>= 20)\n* PATIENT: Reliable telephone and internet access\n* PATIENT: Able to communicate verbally in English and provide informed consent\n* CAREGIVER: Able to communicate verbally in English and provide informed consent\n* CAREGIVER: Reliable telephone and internet access\n\nExclusion Criteria:\n\n* PATIENT: Low symptom burden defined as scores \\< 4 on all ESAS symptoms OR GDS \\< 20\n* PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale \\> 8)\n* PATIENT: No reliable telephone or internet access\n* CAREGIVER: Refusal to participate in this study\n* CAREGIVER: No reliable telephone or internet access'}, 'identificationModule': {'nctId': 'NCT04989556', 'briefTitle': 'Technology-Enhanced Palliative Care for Advanced Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Technology-Enhanced Palliative Care for Cancer Patients', 'orgStudyIdInfo': {'id': '2019-1052'}, 'secondaryIdInfos': [{'id': 'NCI-2020-07465', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-1052', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (standard symptom management)', 'description': 'Patients receive standard symptom management by palliative care team once every 4 weeks for 12 weeks. Patients and caregivers also may participate in an interview with supportive care nurse over 30-45 minutes during week 8.', 'interventionNames': ['Other: Interview', 'Other: Palliative Therapy', 'Other: Quality-of-Life Assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (weekly provider-initiated remote contact)', 'description': 'Patients in Phase I immunotherapy trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact every week. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.', 'interventionNames': ['Other: Interview', 'Other: Palliative Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (weekly provider-initiated remote contact)', 'description': 'Patients in Phase I non-immunotherapy clinical trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact once a week. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.', 'interventionNames': ['Other: Interview', 'Other: Palliative Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Participate in interview', 'armGroupLabels': ['Arm I (standard symptom management)', 'Arm II (weekly provider-initiated remote contact)', 'Arm III (weekly provider-initiated remote contact)']}, {'name': 'Palliative Therapy', 'type': 'OTHER', 'otherNames': ['Comfort Care', 'PA-Palliative Therapy', 'palliation', 'Palliative', 'Palliative Care', 'Palliative Treatment', 'Symptom Management', 'Symptoms Management'], 'description': 'Receive standard symptom management by palliative care team', 'armGroupLabels': ['Arm I (standard symptom management)', 'Arm II (weekly provider-initiated remote contact)', 'Arm III (weekly provider-initiated remote contact)']}, {'name': 'Palliative Therapy', 'type': 'OTHER', 'otherNames': ['Comfort Care', 'PA-Palliative Therapy', 'palliation', 'Palliative', 'Palliative Care', 'Palliative Treatment', 'Symptom Management', 'Symptoms Management'], 'description': 'Receive provider initiated remote contact', 'armGroupLabels': ['Arm II (weekly provider-initiated remote contact)', 'Arm III (weekly provider-initiated remote contact)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (standard symptom management)', 'Arm II (weekly provider-initiated remote contact)', 'Arm III (weekly provider-initiated remote contact)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaire', 'armGroupLabels': ['Arm II (weekly provider-initiated remote contact)', 'Arm III (weekly provider-initiated remote contact)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}