Cancer ColorectalNCT07091032
Building Connections
A study testing Treatment as Usual and Building Connections Intervention in people with Cancer Colorectal and Cancer Cervix, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Colorectal, Cancer Cervix, Depression, Anxiety
- What is being tested?
- Treatment as Usual and Building Connections Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Disparities Research Unit, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Building Connections Between Practices, Patients, and Community Health
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.
- Conditions
- Cancer Colorectal, Cancer Cervix, Depression, Anxiety, Obesity
- Being tested
- Treatment as Usual, Building Connections Intervention
- Medical subject headings
- Colonic Neoplasms, Uterine Cervical Neoplasms, Depression, Anxiety Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualOther
This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.
Building Connections InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | This comparison condition will involve treatment as usual at the clinical sites. Receives: Other: Treatment as Usual |
| Intervention | Experimental | The Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health. Receives: Behavioral: Building Connections Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported height/weight for Body Mass Index (BMI)
Calculation of Body Mass Index
Measured: 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
Measured: Baseline, month 6, month 12
Computerized Adaptive Testing (CAT) of Mental Health (MH)
CAT-MH Depression/MDD and Anxiety
Measured: Baseline, month 6, month 12
Secondary outcomes (3)
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.
Measured: Baseline, month 6, month 12
Cancer screening test type
Screening test type used by people who completed a screening
Measured: 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.
Measured: Baseline, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start7 Aug 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091032
- Sponsor's protocol ID
- 2025P000661
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Connections Between Practices, Patients, and Community Health
- ClinicalTrials.gov ID
- NCT07091032
- Acronym / sponsor ID
- 2025P000661
- Conditions
- Cancer Colorectal, Cancer Cervix, Depression, Anxiety, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as UsualThis comparison condition will involve treatment as usual at the clinical sites. |
| Intervention | Experimental | Behavioral: Building Connections InterventionThe Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as UsualThis is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic. | Other | Treatment as Usual (TAU) |
| Building Connections InterventionThe 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. | Behavioural | Intervention |
Primary outcome
Self-reported height/weight for Body Mass Index (BMI)
Time frame: Baseline, month 6, and month 12
Calculation of Body Mass Index
Rate of cancer screening test completion
Time frame: 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)
Time frame: Baseline, month 6, month 12
CAT-MH Depression/MDD and Anxiety
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual and Building Connections Intervention in people with Cancer Colorectal and Cancer Cervix, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margarita Alegria, Ph.D. (617-724-1237, malegria@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported height/weight for Body Mass Index (BMI) (time frame: Baseline, month 6, and month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.