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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual (TAU) | Active Comparator | This comparison condition will involve treatment as usual at the clinical sites. |
|
| Intervention | Experimental | The Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as Usual | Other | This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported height/weight for Body Mass Index (BMI) | Calculation of Body Mass Index | 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 | Baseline, month 6, month 12 |
| Computerized Adaptive Testing (CAT) of Mental Health (MH) | CAT-MH Depression/MDD and Anxiety | Baseline, month 6, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Prime Diet Quality Score Screener (rPDQS) | 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. |
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Inclusion 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:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margarita Alegria, Ph.D. | Contact | 617-724-1237 | malegria@mgh.harvard.edu | |
| Sheri Markle, MIA | Contact | 617-724-1237 | smarkle@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disparities Research Unit, Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Building Connections Intervention | Behavioral | 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. |
|
| Baseline, month 6, month 12 |
| Cancer screening test type | Screening test type used by people who completed a screening | Baseline, month 6, month 12 |
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 | 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. | Baseline, month 6, month 12 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |