Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-04 @ 2:59 AM
Study NCT ID:
NCT02465892
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pillars4Life Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic pain', 'timeFrame': '9 weeks', 'description': 'Subjects will report how much chronic pain they have and how they are coping with it.'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': '9 weeks', 'description': 'Subjects will report how much stress they are under they have and how they are coping with it.'}, {'measure': 'Anxiety', 'timeFrame': '9 weeks', 'description': 'Subjects will report how much anxiety they have and how they are coping with it.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'stress', 'chronic pain', 'anxiety', 'coping', 'balance', 'online course', 'psychosocial', 'support', 'tools'], 'conditions': ['Breast Cancer', 'Lung Cancer', 'Esophageal Cancer', 'Colon Cancer', 'Pancreatic Cancer', 'Liver Cancer', 'Renal Cancer', 'Bladder Cancer', 'Prostate Cancer', 'Ovarian Cancer', 'Cervical Cancer', 'Uterine Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to explore whether cancer patients can benefit from completing the Pillars4Life online coping program. This randomized control trial will have half its subject completing the program and the other half receiving standard care in order to measure whether the program is beneficial in dealing with stress, anxiety, and particularly chronic pain that often accompany a cancer diagnosis.', 'detailedDescription': 'Subjects will complete three online surveys as part of the study. Each subject who completes the first survey will be randomized to either the control group who receive standard care from their care team or to complete the 9-week Pillars4Life curriculum. Subjects completing the Pillars4Life program will select a course day/time that works for them from those offered. Each week the program will send an email approximately 15 minutes before class time with a link. Subjects will click the link to go to the "classroom," where they will enter their name and phone number. The program will call the number provided and the subject will listen to the audio over the phone, while watching the guide and activities in the virtual classroom on their computer. Each class will last about an hour.\n\nAll subjects will complete two additional surveys, at approximately 9 weeks and 18 weeks after enrolling in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current pain level ≥3 and at least one prior score ≥3 on a 0-10 scale as reported in EPIC;\n* Age ≥18 years\n* Diagnosed with Breast, GI, GU, GYN, or Thoracic cancer\n* Actively receiving care at the Duke Cancer Center, Durham Regional Hospital, or Duke Raleigh Hospital\n* Able/willing to have an online interaction with the Pillars4Life online CORE program curriculum\n* Life expectancy ≥6 months\n* Providing informed consent\n* Able to read/write English.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02465892', 'acronym': 'Pillars4Life', 'briefTitle': 'Pillars4Life Trial', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pillars4Life Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Pro00061381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Subjects in this group will continue receiving standard care from their provider team.'}, {'type': 'EXPERIMENTAL', 'label': 'Pillars4Life', 'description': 'Subjects in this group will complete the Pillars4Life online coping skills curriculum.', 'interventionNames': ['Behavioral: Pillars4Life']}], 'interventions': [{'name': 'Pillars4Life', 'type': 'BEHAVIORAL', 'description': 'The Pillars4Life program will guide participants through activities that will help to identify stress and anxiety triggers, plan ways to cope with the stress of life and cancer, manage anxiety, deal with chronic pain, and balance competing priorities in life.', 'armGroupLabels': ['Pillars4Life']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sophia K Smith, PhD, MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}