| NCT ID | NCT06936878 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-05-12 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.
Eligibility Criteria
Participant Inclusion Criteria: * Age ≥18 years * Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient * Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar) * Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC) * Plans to receive ongoing cancer treatment * Has a family caregiver or friend (hereafter designated family caregiver) willing to participate * Able to speak and read English or Spanish (self-report) * Are willing to be audio-recorded * Have the cognitive/physical ability to participate in a 60-minute interview Family or Caregiver Inclusion Criteria: * Age ≥ 18 years * Identified by a patient (as defined above) as a family or friend who is involved in their care. * Willing to participate in study visits * Willing to be audio recorded Participant Exclusion Criteria: * Has cognitive impairments (as determined by the patient's oncologist) * Planning to enroll in hospice * Unable to complete baseline survey * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners Family or Caregiver Exclusion Criteria: * Unable to complete baseline survey * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners
Contact & Investigator
Alexi Wright, MD MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06936878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936878 currently recruiting?
Yes, NCT06936878 is actively recruiting participants. Contact the research team at alexi_wright@dfci.harvard.edu for enrollment information.
Where is the NCT06936878 trial being conducted?
This trial is being conducted at Boston, United States, Houston, United States.
Who is sponsoring the NCT06936878 clinical trial?
NCT06936878 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Alexi Wright, MD MPH at Dana-Farber Cancer Institute. The trial plans to enroll 600 participants.
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