Building Connections: improving cancer screening, weight management, and mental health for adults in vulnerable communities
Building Connections Between Practices, Patients, and Community Health
This program will try to improve cancer screening, weight management, and mental health care for adults served by community clinics in Massachusetts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07091032 on ClinicalTrials.gov |
What this trial studies
Building Connections partners with clinical practices across Massachusetts, particularly community clinics and health centers, to deliver evidence-based interventions for obesity/weight management, colorectal and cervical cancer screening, and moderate-to-severe depression or anxiety. Adults aged 18+ who speak English or Spanish and meet condition-specific criteria (BMI ≥30 for obesity; overdue colorectal screening for ages 45–75; overdue cervical screening for ages 30–65; or moderate-to-severe depression or anxiety symptoms) are eligible. Participants receive either the Building Connections intervention or treatment as usual, and outcomes include screening completion, weight change, and mental health symptom change. The program is designed to reduce healthcare inequities by tailoring interventions to socially vulnerable populations served by participating clinics.
Who should consider this trial
Good fit: Adults aged 18 or older who speak English or Spanish and who have obesity (BMI ≥30), are due for colorectal or cervical cancer screening per the listed age windows, or have moderate-to-severe depression or anxiety, and who receive care at participating Massachusetts clinics.
Not a fit: Patients who are already up-to-date on recommended cancer screenings, have BMI below 30 without weight concerns, have only mild or no mental health symptoms, or cannot engage in English or Spanish may be unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the program could increase cancer screening uptake, improve weight outcomes, and reduce depression and anxiety symptoms in socially vulnerable patient populations.
How similar studies have performed: Individual approaches like outreach to increase screening, behavioral weight-loss programs, and collaborative mental health care have shown benefits in prior studies, but combining these evidence-based interventions into a single program targeted to socially vulnerable clinics is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Boston, Massachusetts
- Disparities Research Unit, Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Margarita Alegria, Ph.D.
- Email: malegria@mgh.harvard.edu
- Phone: 617-724-1237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.