Viewing Study NCT06063603


Ignite Creation Date: 2025-12-24 @ 7:32 PM
Ignite Modification Date: 2025-12-29 @ 2:37 AM
Study NCT ID: NCT06063603
Status: COMPLETED
Last Update Posted: 2025-09-18
First Post: 2023-09-13
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D008405', 'term': 'Massage'}, {'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D059408', 'term': 'Pain Management'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D000070659', 'term': 'Patient Comfort'}, {'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'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': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D019468', 'term': 'Disease Management'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cheville.andrea@mayo.edu', 'phone': '507-284-2511', 'title': 'Andrea L. Cheville, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 days', 'description': 'Groups II and III did not participate in the intervention and were not enrolled to the study. Adverse events were not collected from the provider and interventionalist participants in Group II or III.', 'eventGroups': [{'id': 'EG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II (Intervention Providers)', 'description': 'Group II participants were not enrolled to the study and participated only in study development.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group III (Medical Oncology Providers)', 'description': 'Group III participants were not enrolled to the study and participated only in study development.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'title': 'Completed intake visit, planning visit, and final visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Utilized materials sent to the portal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Utilized mailed materials that discussed pain management techniques', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Utilized ASCENT website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Utilized follow-up phone calls with a member of the ASCENT team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Utilized the Action Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by proportion of participants who received key intervention components.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed all three visits were sent a survey about their experience with the ASCENT pilot--of the 41 who completed all 3 visits, 35 completed the survey.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention - Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Once', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Every other week', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Weekly', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Multiple times a week', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'As assessed by frequency of participant interaction with care team.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention - Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'categories': [{'title': 'Not satisfied with frequency of communication with a member of the ASCENT care team', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Satisfied with frequency of communication with a member of the ASCENT care team', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'As assessed by participant satisfaction with care team interactions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Utility of Intervention - Helpfulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'title': 'Helpfulness of working with the ASCENT care team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of the materials sent to the patient portal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of the mailed materials that discussed different pain management techniques', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of the ASCENT website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of the follow-up phone calls with a member of the ASCENT team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of the Action Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not at all helpful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat helpful', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Helpful', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very helpful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extremely helpful', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were asked about the helpfulness of specific components of the ASCENT intervention if and only if they utilized that component.'}, {'type': 'PRIMARY', 'title': 'Utility of Intervention - Confidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'title': 'Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan', 'categories': [{'title': 'Not at all confident', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Confident', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Very confident', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Extremely confident', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'N/A', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Confidence in ability to find resources to help with pain', 'categories': [{'title': 'Not at all confident', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Confident', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Very confident', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Extremely confident', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'N/A', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Confidence in managing pain better in the future', 'categories': [{'title': 'Not at all confident', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Confident', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Very confident', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Extremely confident', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'N/A', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Five patients did not set goals and thus the question about setting goals with the care team was not applicable.'}, {'type': 'PRIMARY', 'title': 'Utility of Intervention - Ease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'classes': [{'title': 'Ease of understanding materials sent to the patient portal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither easy nor difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very easy', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Ease of understanding mailed materials that discussed pain management techniques', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither easy nor difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very easy', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Ease of understanding the ASCENT website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither easy nor difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very easy', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Ease of understanding follow-up phone calls with a member of the ASCENT team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither easy nor difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Very easy', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Ease of understanding the Action Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither easy nor difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very easy', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were asked about the ease of use of specific components of the ASCENT intervention if and only if they utilized these components. Five participants did not utilize these components.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy(CBT): Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with pain care manager (PCM) and community health worker (CHW) for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Group 2 (Intervention Providers)', 'description': 'Study interventionalists complete an interview on study.'}, {'id': 'FG002', 'title': 'Group 3 (Medical Oncology Providers)', 'description': 'Medical oncology providers participate in a focus group on study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Completed Intake Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Planning Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Final Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participated in Focus Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': "Participated in Interventionalist's Interview", 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Only Group 1 were actual participants who were enrolled in the study and received the intervention. Data was only collected for Group 1, so this is the only data reported.\n\nGroup 2 consisted of interventionalists (provided the intervention to Group 1 participants). Group 3 were Medical Oncology providers. Neither Group 2 nor 3 received any intervention or were enrolled in the study. Groups 2 and 3 participated only in study development.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I (Pain Management)', 'description': 'See detailed description.\n\nAcupuncture Therapy: Undergo acupuncture therapy\n\nCancer Pain Management: Receive pain clinic referral\n\nCognitive Behavior Therapy: Undergo CBT\n\nEducational Intervention: Receive self-guided pain management education materials\n\nExercise: Participate in exercise\n\nInterview: Complete interview\n\nMassage Therapy: Receive massage\n\nMindfulness Relaxation: Practice mindfulness\n\nPain Therapy: Receive pain treatment/medicine\n\nPalliative Therapy: Receive palliative care referral\n\nPatient Navigation: Undergo visits with PCM and CHW for pain management\n\nReferral: Receive pain management referrals\n\nSpiritual Therapy: Receive spiritual support\n\nSpiritual Care Referral: Receive spiritual care referral\n\nSurvey Administration: Ancillary studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.03922', 'spread': '12.69167', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rural-Urban Commuting Area (RUCA) category', 'classes': [{'categories': [{'title': 'Urban (RUCA 1-3)', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Large rural (RUCA 4-6)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Small rural (RUCA 7-9)', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Rural (RUCA 10)', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer type', 'classes': [{'categories': [{'title': 'Breast', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Endocrine', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'GI', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'GYN', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genitourinary', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Head and neck', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Heme', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Lung', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Melanoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Groups II and III were not enrolled to the study. They participated in development and evaluation of this pilot as providers. These groups did not receive the study intervention, and no demographic or outcome data was collected from these groups. Only data from Group 1 is reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-03', 'size': 390829, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-30T11:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2023-09-13', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-28', 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by proportion of participants who received key intervention components.'}, {'measure': 'Acceptability of Intervention - Interaction', 'timeFrame': 'Up to 60 days', 'description': 'As assessed by frequency of participant interaction with care team.'}, {'measure': 'Acceptability of Intervention - Satisfaction', 'timeFrame': 'Up to 60 days', 'description': 'As assessed by participant satisfaction with care team interactions'}, {'measure': 'Utility of Intervention - Helpfulness', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.'}, {'measure': 'Utility of Intervention - Confidence', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.'}, {'measure': 'Utility of Intervention - Ease', 'timeFrame': 'Up to 60 days', 'description': 'Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Leukemia', 'Hematopoietic and Lymphoid System Neoplasm', 'Lymphoma', 'Malignant Solid Neoplasm', 'Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. Cancer pain is prevalent, under treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors.\n\nGROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study.\n\nGROUP II: ASCENT study interventionists complete an interview on study.\n\nGROUP III: Medical oncology providers participate in a focus group on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site\n* Age 18+\n* Numerical rating scale (NRS) pain score of a 5+ out of 10\n* Pain that developed (onset) or significantly worsened since cancer diagnosis\n* Malignant hematology including:\n\n * Lymphoma\n * Myeloma\n * Chronic leukemias\n\nExclusion Criteria:\n\n* Patient Health Questionnaire (PHQ) 8 score of 10 or more\n* Life expectancy less than 12 months\n* Hospice enrollment\n* Admitted to hospital from long term care/skilled nursing facilities (SNF)\n* Acute leukemias\n* Primary brain tumors\n* Confinement to a bed or a chair more than a third of waking hours because of health complications'}, 'identificationModule': {'nctId': 'NCT06063603', 'briefTitle': 'Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)', 'orgStudyIdInfo': {'id': 'ASCENT_Pilot'}, 'secondaryIdInfos': [{'id': 'NCI-2023-05223', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ASCENT', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}, {'id': '23-004139', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Pain management)', 'description': 'See detailed description.', 'interventionNames': ['Procedure: Acupuncture Therapy', 'Behavioral: Cancer Pain Management', 'Behavioral: Cognitive Behavior Therapy', 'Other: Educational Intervention', 'Other: Exercise', 'Other: Interview', 'Procedure: Massage Therapy', 'Behavioral: Mindfulness Relaxation', 'Procedure: Pain Therapy', 'Other: Palliative Therapy', 'Behavioral: Patient Navigation', 'Other: Referral', 'Procedure: Spiritual Therapy', 'Procedure: Spiritual Care Referral', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (Interview)', 'description': 'ASCENT study interventionists complete an interview on study.', 'interventionNames': ['Other: Interview']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (Focus group)', 'description': 'Medical oncology providers participate in a focus group on study.', 'interventionNames': ['Procedure: Discussion']}], 'interventions': [{'name': 'Acupuncture Therapy', 'type': 'PROCEDURE', 'otherNames': ['Acupuncture'], 'description': 'Undergo acupuncture therapy', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Cancer Pain Management', 'type': 'BEHAVIORAL', 'otherNames': ['management of cancer pain'], 'description': 'Receive pain clinic referral', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT', 'cognitive therapy', 'CT'], 'description': 'Undergo CBT', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Discussion', 'type': 'PROCEDURE', 'otherNames': ['Discuss'], 'description': 'Participate in focus group', 'armGroupLabels': ['Group III (Focus group)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive self-guided pain management education materials', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Exercise', 'type': 'OTHER', 'otherNames': ['Exercise Type'], 'description': 'Participate in exercise', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Complete interview', 'armGroupLabels': ['Group I (Pain management)', 'Group II (Interview)']}, {'name': 'Massage Therapy', 'type': 'PROCEDURE', 'otherNames': ['Massage'], 'description': 'Receive massage', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Mindfulness Relaxation', 'type': 'BEHAVIORAL', 'otherNames': ['MBSR', 'Mindful Meditation', 'Mindfulness Meditation', 'Mindfulness-Based Stress Reduction'], 'description': 'Practice mindfulness', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Pain Therapy', 'type': 'PROCEDURE', 'otherNames': ['Analgesia', 'Pain Control', 'Pain Management', 'Pain, Pain Management'], 'description': 'Receive pain treatment/medicine', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Palliative Therapy', 'type': 'OTHER', 'otherNames': ['Comfort Care', 'PA-Palliative Therapy', 'palliation', 'Palliative', 'Palliative Care', 'Palliative Treatment', 'Symptom Management', 'Symptoms Management'], 'description': 'Receive palliative care referral', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Patient Navigation', 'type': 'BEHAVIORAL', 'otherNames': ['Patient Navigator Program'], 'description': 'Undergo visits with PCM and CHW for pain management', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Referral', 'type': 'OTHER', 'otherNames': ['Referred'], 'description': 'Receive pain management referrals', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Spiritual Therapy', 'type': 'PROCEDURE', 'description': 'Receive spiritual support', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Spiritual Care Referral', 'type': 'PROCEDURE', 'description': 'Receive spiritual care referral', 'armGroupLabels': ['Group I (Pain management)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (Pain management)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Andrea L. Cheville, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}