Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT04462302
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Internet-based Program to Help Cancer Survivors Manage Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D010146', 'term': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 456}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': 'Change from Baseline to 10 week', 'description': 'The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Pain Interference', 'timeFrame': 'Change from Baseline to 10 week', 'description': 'The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).'}], 'secondaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': '22 and 34 weeks', 'description': 'The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Pain Interference', 'timeFrame': '22 and 34 weeks', 'description': 'The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).'}, {'measure': 'Opioid/analgesic medication use', 'timeFrame': 'Baseline and 10 week', 'description': 'A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).'}, {'measure': 'Opioid/analgesic medication use', 'timeFrame': 'Baseline, 10, 22, and 24 week', 'description': "7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME)."}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Baseline, 10, 22, and 24 week', 'description': 'Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.'}, {'measure': 'Pain Management Self-Efficacy', 'timeFrame': 'Baseline, 10, 22, and 24 week', 'description': 'Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer pain', 'Survivor', 'Pain', 'Pain coping'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.', 'detailedDescription': 'This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.\n\nEach participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMust have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.\n\n* May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.\n\n * Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.\n * Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment.\n * A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.\n * A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).\n * In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint.\n* Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).\n* Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.\n* Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.\n* Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.\n* Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment\n* Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).\n* ECOG performance status of 0, 1, or 2.\n* Age ≥18 years at the time of study entry\n* Must be able to speak, read and understand English.\n\nExclusion Criteria:\n\n* Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.\n* Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).\n* Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.\n* Currently being prescribed buprenorphine or suboxone.\n* Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.\n* Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.\n* Does not have a working email address.'}, 'identificationModule': {'nctId': 'NCT04462302', 'acronym': 'IMPACTS', 'briefTitle': 'An Internet-based Program to Help Cancer Survivors Manage Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Internet-delivered Management of Pain Among Cancer Treatment Survivors', 'orgStudyIdInfo': {'id': 'IRB00066906'}, 'secondaryIdInfos': [{'id': '3UG1CA189824-06S1', 'link': 'https://reporter.nih.gov/quickSearch/3UG1CA189824-06S1', 'type': 'NIH'}, {'id': 'WF-1901', 'type': 'OTHER', 'domain': 'Wake Forest NCORP Research Base'}, {'id': 'NCI-2020-02315', 'type': 'REGISTRY', 'domain': 'NCI CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based program + Pain Education', 'description': 'If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.', 'interventionNames': ['Behavioral: Internet-based pain coping skills program']}, {'type': 'NO_INTERVENTION', 'label': 'Pain Education Only', 'description': 'If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.'}], 'interventions': [{'name': 'Internet-based pain coping skills program', 'type': 'BEHAVIORAL', 'description': 'The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.', 'armGroupLabels': ['Internet-based program + Pain Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '800-378-9373'}, {'name': 'Jay W Carlson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Hospital Fort Smith', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Deer Valley Medical Center', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Fremont', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Oakland', 'geoPoint': {'lat': 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'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95814', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Downtown Commons', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-South Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 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Rafael', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser San Rafael-Gallinas', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Medical Center - Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Santa Rosa', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greys-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-South San Francisco', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '95210', 'city': 'Stockton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Stockton', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '95688', 'city': 'Vacaville', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Medical Center-Vacaville', 'geoPoint': {'lat': 38.35658, 'lon': -121.98774}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Natalya Greyz-Yusupov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Vallejo', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'kristi.m.bronkan@kp.org', 'phone': '303-720-2685'}, {'name': 'Alexander Menter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Franklin', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'kristi.m.bronkan@kp.org', 'phone': '303-720-2685'}, {'name': 'Alexander Menter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Rock Creek', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'kristi.m.bronkan@kp.org', 'phone': '303-720-2685'}, {'name': 'Alexander Menter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Lone Tree', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'cdean@iacthealth.com', 'phone': '706-478-7968'}, {'name': 'Andrew W Pippas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John B. 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