Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 12:30 AM
Study NCT ID:
NCT07300995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Pain Intervention for Older Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity as measured by the Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline, 10-week assessment, 15-week assessment', 'description': 'BPI Pain Severity (worst, least, average, current pain on 0-10 scale) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain severity.'}, {'measure': 'Pain interference as measured by the Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline, 10-week assessment, 15-week assessment', 'description': 'BPI Pain Interference (7 daily life areas such as mood, sleep, activity rated 0-10) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain interference.'}, {'measure': 'Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function', 'timeFrame': 'Baseline, 10-week assessment, 15-week assessment', 'description': 'A PROMIS Physical Function T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported physical ability with higher scores indicating better function.'}, {'measure': 'Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Mental Health', 'timeFrame': 'Baseline, 10-week assessment, 15-week assessment', 'description': 'A PROMIS Mental Health T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported mental health with higher scores indicating worse mental health.'}], 'secondaryOutcomes': [{'measure': 'Self-Efficacy for Pain Management', 'timeFrame': 'Baseline, 10-week assessment, 15-week assessment', 'description': 'The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item scale rating confidence (0-6) in specific tasks despite pain. The total score ranges from 0 to 60, where higher scores indicate greater self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'pain', 'coping', 'symptom management'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.', 'detailedDescription': 'Pain continues to be persistent, interfering, and distressing for women with breast cancer. Behavioral cancer pain interventions continue to be poorly implemented with pronounced disparities for older breast cancer patients receiving oncology care in medically underserved areas. Within this context, this randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving cancer care at a Duke Cancer Network (DCN) clinic\n* Stage I-IV breast cancer\n* Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week\n* Biologically female\n* Greater than or equal to 55 years old\n* Ability to speak and read English\n* Hearing and vision that allows for successful completion of videoconferencing and phone session\n\nExclusion Criteria:\n\n* Participation in the last 6 months in a pain coping skills training program'}, 'identificationModule': {'nctId': 'NCT07300995', 'briefTitle': 'Behavioral Pain Intervention for Older Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Behavioral Pain Intervention for Older Breast Cancer Patients in Medically Underserved Areas', 'orgStudyIdInfo': {'id': 'Pro00117948'}, 'secondaryIdInfos': [{'id': 'P30AG022845', 'link': 'https://reporter.nih.gov/quickSearch/P30AG022845', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Coping Skills Training', 'description': 'Participants in this group will complete a 50-minute telehealth session with a trained study nurse. During this session, they will be taught how to use several coping strategies for managing pain. This will be followed by 5 weekly, 15-minute supportive phone calls, where the study nurse will reinforce the learned coping skills. They will be asked to complete 2 follow-up surveys (10 weeks and 15 weeks after the first survey).', 'interventionNames': ['Behavioral: Pain Coping Skills Training (PCST)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants in this group will not complete the new program. They will be asked to complete 2 follow-up surveys (10 and 15 weeks after the first survey).'}], 'interventions': [{'name': 'Pain Coping Skills Training (PCST)', 'type': 'BEHAVIORAL', 'description': 'Behavioral pain intervention delivered via telehealth.', 'armGroupLabels': ['Pain Coping Skills Training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tamara Somers, PhD', 'role': 'CONTACT', 'email': 'tamara.somers@duke.edu', 'phone': '919-416-3408'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}