Cancer Cervix, Cancer Colorectal, Depression, Anxiety, Obesity
Conditions
Brief 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.
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported height/weight for Body Mass Index (BMI) | Baseline, month 6, and month 12 | Calculation of Body Mass Index |
| Rate of cancer screening test completion | Baseline, month 6, month 12 | Number of eligible people who complete a screening test out of total eligible |
| Computerized Adaptive Testing (CAT) of Mental Health (MH) | Baseline, month 6, month 12 | CAT-MH Depression/MDD and Anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer screening test type | Baseline, month 6, month 12 | Screening test type used by people who completed a screening |
| Rapid Prime Diet Quality Score Screener (rPDQS) | Baseline, month 6, month 12 | 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. |
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 | Baseline, month 6, month 12 | 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. |
Countries
United States
Contacts
Primary ContactMargarita Alegria, Ph.D.
Backup ContactSheri Markle, MIA
Outcome results
None listed