Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

Building Connections Between Practices, Patients, and Community Health

NCT ID: NCT07091032Sponsor: Massachusetts General HospitalLast updated: 2025-11-18

Summary

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.

Arms & interventions

  • OtherTreatment as Usual

    This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.

  • BehavioralBuilding Connections Intervention

    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.

Outcome measures

Primary

  • Self-reported height/weight for Body Mass Index (BMI)

    Calculation of Body Mass Index

    Time frame: Baseline, month 6, and month 12

  • Rate of cancer screening test completion

    Number of eligible people who complete a screening test out of total eligible

    Time frame: Baseline, month 6, month 12

  • Computerized Adaptive Testing (CAT) of Mental Health (MH)

    CAT-MH Depression/MDD and Anxiety

    Time frame: Baseline, month 6, month 12

Secondary

  • Rapid Prime Diet Quality Score Screener (rPDQS)

    Time frame: Baseline, month 6, month 12

  • Cancer screening test type

    Time frame: Baseline, month 6, month 12

  • World Health Organization Disability Assessment Schedule (WHODAS) 2.0

    Time frame: Baseline, month 6, month 12

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No
Inclusion Criteria: * The general inclusion criteria involve being 18+, speaking English or Spanish, and meeting one or more of the following criteria: Obesity: Patients with a body mass index of 30 kg/m2 or greater (i.e., obese category). Cancer screening: Average-risk patients without recommended colorectal or cervical cancer screenings for their age group and biological sex. Specifically: Colon 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. And/or Cervical 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. Mental health: Patients with moderate to severe depression or anxiety symptoms. Exclusion Criteria: * 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. Exclusion 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. Exclusion criteria for cancer screening intervention include: Colon Cancer (CRC) exclusion criteria: has colorectal cancer documented in the problem list; has ulcerative colitis or Crohn's disease documented in the problem list Cervical cancer exclusion criteria: has cervical cancer documented in the problem list; has had a prior hysterectomy. Exclusion 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).

Study locations (1)

Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting
Building Connections | Cancerify