Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-19 @ 4:51 PM
Study NCT ID:
NCT02430467
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2015-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caregiver-Guided Pain Management Training in Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in caregiver self-efficacy for helping the patient manage pain', 'timeFrame': 'baseline, post-intervention (3 weeks)', 'description': 'Caregiver Self-Efficacy Scale'}], 'secondaryOutcomes': [{'measure': 'Change in caregiver strain', 'timeFrame': 'baseline, following intervention (3 weeks)', 'description': 'Caregiver Strain Index'}, {'measure': 'Change in caregiver satisfaction', 'timeFrame': 'baseline, following intervention (3 weeks)', 'description': 'Caregiving Satisfaction Scale'}, {'measure': 'Change in caregiver psychological distress', 'timeFrame': 'baseline, following intervention (3 weeks)', 'description': 'Center for Epidemiology Studies Short Depression Scale'}, {'measure': 'Change in caregiver psychological distress', 'timeFrame': 'following death of patient (3 mos & 6 mos)', 'description': 'Trait Anxiety Scale'}, {'measure': 'Change in caregiver health behaviors', 'timeFrame': 'following death of patient (3 mos & 6 mos)', 'description': 'Self-Administered Comorbidity Questionnaire'}, {'measure': 'Change in caregiver global health rating', 'timeFrame': 'following death of patient (3 mos & 6 mos)', 'description': 'Global health rating'}, {'measure': 'Change in patient pain', 'timeFrame': 'baseline, post-intervention (3 weeks)', 'description': 'Brief Pain Inventory'}, {'measure': 'Change in patient self-efficacy', 'timeFrame': 'baseline, post-intervention (3 weeks)', 'description': 'Patient Self-Efficacy Scale'}, {'measure': 'Change in patient psychological distress', 'timeFrame': 'baseline, post-intervention (3 weeks)', 'description': 'Hospital Anxiety and Depression Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '33775175', 'type': 'DERIVED', 'citation': 'Porter LS, Steel JL, Fairclough DL, LeBlanc TW, Bull J, Hanson LC, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial. Palliat Med. 2021 May;35(5):952-961. doi: 10.1177/02692163211004216. Epub 2021 Mar 29.'}, {'pmid': '30782014', 'type': 'DERIVED', 'citation': 'Porter LS, Samsa G, Steel JL, Hanson LC, LeBlanc TW, Bull J, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study. Clin Trials. 2019 Jun;16(3):263-272. doi: 10.1177/1740774519829695. Epub 2019 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop more effective ways to help patients and their caregivers cope with cancer pain. The investigators are looking at the usefulness of a Caregiver-Guided Pain Management Training Intervention versus Pain Education.', 'detailedDescription': "The primary aim of this study is to test the efficacy for the Caregiver-Guided Pain Management Training intervention to improve the caregiver's self-efficacy for helping the patient manage pain. Secondary aims include testing the effectiveness of the CG-PMT intervention to improve patient pain severity, patient self-efficacy for pain management and patient psychological distress, as well as short-term caregiver adjustment and caregiver adjustment following the patient's death.\n\nIn this multi-site study, 236 dyads (patients with cancer pain and their family caregivers) will be randomized to either a Caregiver-Guided Pain Management Training protocol or to an Enhanced Treatment-as-Usual control condition. Dyads in the Caregiver-Guided Pain Management condition will receive three one-hour sessions conducted via videoconference. Dyads in the Enhanced Treatment-as-Usual condition will receive educational material about cancer pain and its management but will not receive any study-related treatment sessions. Assessments will be conducted with patients and caregivers before and after treatment, and with caregivers 3 months and 6 months following the patient's death. The primary hypothesis to be tested is that caregivers who receive the intervention will report significantly higher levels of self-efficacy for helping the patient manage pain than caregivers in the control condition. Secondary aims will focus on (a) improvements in short-term caregiver adjustment as well as caregiver adjustment following the patient's death, and (b) patient pain severity, self-efficacy for pain management, and psychological distress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n1. clinical diagnosis Stage 4 solid or hematologic malignancy and nonresectable Stage 3 gastrointestinal (GI) cancer\n2. life expectancy of \\< 1 month\n3. worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale,\n4. have an identified caregiver who is also willing to participate,\n5. at least 18 years old, 6) fluent in English.\n\nCaregiver Inclusion Criteria:\n\n1. at least 18 years old\n2. fluent in English\n\nPatient Exclusion Criteria:\n\n1. Palliative Performance Scale rating \\<40,\n2. current external radiation therapy for reduction of pain\n3. unable to provide informed consent or complete study procedures as determined by clinical or study staff.\n\nCaregiver Exclusion Criteria:\n\n1\\) unable to provide informed consent or complete study procedures as determined by clinical or study staff.'}, 'identificationModule': {'nctId': 'NCT02430467', 'briefTitle': 'Caregiver-Guided Pain Management Training in Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Caregiver-Guided Pain Management Training in Palliative Care', 'orgStudyIdInfo': {'id': 'Pro00057512'}, 'secondaryIdInfos': [{'id': '1R01NR015348-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR015348-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caregiver-guided pain management training protocol (CG-PMT)', 'description': 'Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques', 'interventionNames': ['Behavioral: Caregiver-guided pain management training (CG-PMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced treatment-as-usual (TAU)', 'description': 'Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.', 'interventionNames': ['Behavioral: Enhanced treatment-as-usual (TAU)']}], 'interventions': [{'name': 'Caregiver-guided pain management training (CG-PMT)', 'type': 'BEHAVIORAL', 'description': 'Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques.', 'armGroupLabels': ['Caregiver-guided pain management training protocol (CG-PMT)']}, {'name': 'Enhanced treatment-as-usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.', 'armGroupLabels': ['Enhanced treatment-as-usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Laura Porter, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'Palliative Care Research Cooperative Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}