Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT05067556
Status:
SUSPENDED
Last Update Posted:
2025-08-08
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decreasing Long-term Opioid Use in Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'whyStopped': 'Insufficient staffing', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment yield of participants contacted', 'timeFrame': '12 Months', 'description': 'Study feasibility will be assessed by tracking the number of patients contacted'}, {'measure': 'Recruitment yield of participants consented', 'timeFrame': '12 Months', 'description': 'Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.'}, {'measure': 'Recruitment yield number of participants enrolled', 'timeFrame': '12 Months', 'description': 'Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.'}, {'measure': 'Session Attendance', 'timeFrame': '6 Weeks', 'description': 'Study feasibility will be assessed by tracking the number of participants attend each intervention session over the course of the 6-week intervention period.'}, {'measure': 'Participant Satisfaction', 'timeFrame': '6 Weeks', 'description': 'Study acceptability will be assessed by administering a post-intervention satisfaction survey which asks about satisfaction with the program including perceived efficacy and suggestions for improvement.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '6 Weeks', 'description': 'Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by analyzing change in self-reported pain scores using The Patient-Reported Outcome Measurement Information System short form 3a v1.0 (PROMIS). This tool measures how much a person hurts.'}, {'measure': 'Opioid Use Frequency', 'timeFrame': '6 Weeks', 'description': 'Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by self-reported opioid use frequency weekly throughout the intervention period.'}, {'measure': 'Pain interference', 'timeFrame': '6 Weeks', 'description': "Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by analyzing pain interference using the PROMIS short form 8a. The PROMIS Pain Interference instrument measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities."}, {'measure': 'Opioid Refill Frequency', 'timeFrame': '6 Weeks', 'description': "Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Commitment Therapy'], 'conditions': ['Pain', 'Chronic Pain', 'Cancer Pain', 'Survivorship']}, 'descriptionModule': {'briefSummary': 'This is a feasibility pilot trial assessing a behavioral intervention for chronic pain among disease-free cancer survivors to decrease long-term opioid dependence.', 'detailedDescription': 'To assess the feasibility and acceptability of implementing brief Acceptance and Commitment Therapy for chronic pain (ACT-CP) in a Survivorship clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer of any type, currently in remission, having completed active primary therapy. Patients on oral adjuvant hormone therapy will still be eligible.\n* Completed active therapy must have been curative in intent (for example stage IV cancer patients such as head and neck cancer patients treated with curative intent are eligible).\n* Self-reported cancer pain for \\>= 3 months\n* Opioid use \\>= 5MME/day (morphine milligram equivalents) as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment\n* VCUHealth system patient\n\nExclusion Criteria:\n\n* History of opioid use prior to cancer diagnosis\n* Anyone with prior history of substance use disorder or currently enrolled in a methadone program\n* Anyone with schizophrenia or bipolar disorder\n* Current utilization of psychotherapy services for pain, depression, anxiety, and/or PTSD\n* Cognitive concerns that would prevent meaningful engagement in treatment\n* Inability to converse in English\n* Lack of working telephone and Internet connection (must have at least one or the other)\n* Anyone found to have progression of cancer\n* Anyone diagnosed with cancer recurrence or new cancer during their study period\n* Documented diagnosis of or positive screen for current substance use disorder (score \\>5 on the Drug Abuse Screening Test-10 \\[DAST-10\\])\n* Anyone scoring \\>=8 on ORT indicating very high risk for opioid abuse'}, 'identificationModule': {'nctId': 'NCT05067556', 'briefTitle': 'Decreasing Long-term Opioid Use in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use', 'orgStudyIdInfo': {'id': 'MCC-21-18366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy for chronic pain (ACT-CP)', 'type': 'BEHAVIORAL', 'description': 'Delivered virtually via Zoom or via telephone on an individual level; 30-minute sessions led by a trained psychologist and occur weekly for 6 weeks.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Susan Hong, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}