Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 7:50 PM
Study NCT ID:
NCT07091032
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Building Connections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported height/weight for Body Mass Index (BMI)', 'timeFrame': 'Baseline, month 6, and month 12', 'description': 'Calculation of Body Mass Index'}, {'measure': 'Rate of cancer screening test completion', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'Number of eligible people who complete a screening test out of total eligible'}, {'measure': 'Computerized Adaptive Testing (CAT) of Mental Health (MH)', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'CAT-MH Depression/MDD and Anxiety'}], 'secondaryOutcomes': [{'measure': 'Rapid Prime Diet Quality Score Screener (rPDQS)', 'timeFrame': 'Baseline, month 6, month 12', 'description': "The Rapid Prime Diet Quality Score Screener (rPDQS) is a 13-item measure about past month consumption of food, categorized by type (less than once per week to twice per day or more). A logic system assigns points to each item (0 'unhealthy dietary pattern' to 2 'healthy dietary pattern'). Total scores are calculated as the sum of all items (range 0 to 26), and higher scores represent healthier dietary patterns."}, {'measure': 'Cancer screening test type', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'Screening test type used by people who completed a screening'}, {'measure': 'World Health Organization Disability Assessment Schedule (WHODAS) 2.0', 'timeFrame': 'Baseline, month 6, month 12', 'description': "The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 12-item measure of difficulties performing activities in six domains of daily life (1 'None' to 5 'Extreme or cannot do'). Total scores are calculated as the sum of all items (range 12 to 60) and higher scores indicate higher disability."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Colorectal', 'Cancer Cervix', 'Depression, Anxiety', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Building Connections seeks to address health and healthcare inequities in socially vulnerable communities. The project will be conducted in collaboration with clinical practices across Massachusetts, serving a diverse population heavily represented in Community Clinics and Health Centers. The program will offer evidence-based interventions in obesity/weight management, cancer screening, and mental health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The general inclusion criteria involve being 18+, speaking English or Spanish, and meeting one or more of the following criteria:\n\nObesity: Patients with a body mass index of 30 kg/m2 or greater (i.e., obese category).\n\nCancer screening: Average-risk patients without recommended colorectal or cervical cancer screenings for their age group and biological sex. Specifically:\n\nColon Cancer (CRC) inclusion criteria: Patients aged 45-75 who are due for screenings, with last FIT longer than 1 year ago, last colonoscopy longer than 10 years ago, and last Cologuard longer than 3 years ago.\n\nAnd/or\n\nCervical cancer inclusion criteria: Women and patients with a cervix aged 30-65 who are due for screening: with last pap longer than 3 years ago; last co-test longer than 5 years ago; last primary HPV screening longer than 5 years ago.\n\nMental health: Patients with moderate to severe depression or anxiety symptoms.\n\nExclusion Criteria:\n\n* The general exclusion criteria are: those with current pregnancy, or the participant is cognitively impaired, not having a visit to the primary care clinic in the prior 2 years, and speaking a language other than English or Spanish.\n\nExclusion criteria for obesity intervention: had prior metabolic or bariatric surgery or planning to have this surgery in the next 6 months, currently enrolled in an intensive lifestyle program.\n\nExclusion criteria for cancer screening intervention include:\n\nColon Cancer (CRC) exclusion criteria: has colorectal cancer documented in the problem list; has ulcerative colitis or Crohn's disease documented in the problem list\n\nCervical cancer exclusion criteria: has cervical cancer documented in the problem list; has had a prior hysterectomy.\n\nExclusion criteria for mental health: include patients with active suicidality, active substance use disorder, a history of schizophrenia or bipolar disorder, or who are already receiving behavioral health care (therapy sessions in the past 3 months or an appointment upcoming in the next month)."}, 'identificationModule': {'nctId': 'NCT07091032', 'briefTitle': 'Building Connections', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Building Connections Between Practices, Patients, and Community Health', 'orgStudyIdInfo': {'id': '2025P000661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual (TAU)', 'description': 'This comparison condition will involve treatment as usual at the clinical sites.', 'interventionNames': ['Other: Treatment as Usual']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health.', 'interventionNames': ['Behavioral: Building Connections Intervention']}], 'interventions': [{'name': 'Treatment as Usual', 'type': 'OTHER', 'description': 'This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.', 'armGroupLabels': ['Treatment as Usual (TAU)']}, {'name': 'Building Connections Intervention', 'type': 'BEHAVIORAL', 'description': 'The combined Building Connections intervention incorporates three areas. Participants take part in those for which they are eligible. The obesity/weight management intervention offers coaching and support for education on evidence-based anti-obesity medications (AOM) and a lifestyle behavioral intervention offered by Community Health Workers focused on diet and physical activity. The cancer screening intervention focuses on developing workflows and systems to offer a CHW-delivered population-based intervention to improve colorectal and cervical cancer, focusing on newer screening modalities and monitoring adherence for individuals with a positive screening test result. The mental health intervention uses the evidence-based Strong Minds intervention, a 10-session psychoeducational program provided by trained community health workers with clinical supervision. The skills-based intervention uses an integrative approach aimed at improving depression, anxiety, and trauma-related symptoms.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Disparities Research Unit, Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Margarita Alegria, Ph.D.', 'role': 'CONTACT', 'email': 'malegria@mgh.harvard.edu', 'phone': '617-724-1237'}, {'name': 'Sheri Markle, MIA', 'role': 'CONTACT', 'email': 'smarkle@mgh.harvard.edu', 'phone': '617-724-1237'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Disparities Research Unit', 'investigatorFullName': 'Margarita Alegria, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}