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Recruiting NCT07091032

Building Connections

No phase Interventional Cancer Colorectal Cancer Cervix Depression, Anxiety Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment as Usual, Building Connections Intervention.
Who it may be relevant to
Registry conditions: Cancer Colorectal, Cancer Cervix, Depression, Anxiety, Obesity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Building Connections Between Practices, Patients, and Community Health

Overview

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.

Interventions

  • Other Treatment as Usual
    This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.
  • Behavioral Building 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-bas

Primary outcome measures

  • Self-reported height/weight for Body Mass Index (BMI) [Time frame: Baseline, month 6, and month 12]
  • Rate of cancer screening test completion [Time frame: Baseline, month 6, month 12]
  • Computerized Adaptive Testing (CAT) of Mental Health (MH) [Time frame: Baseline, month 6, month 12]
Secondary outcome measures (3)
  • 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

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Disparities Research Unit, Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07091032 · 2025P000661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗