Program to support patients with advanced gastrointestinal and gynecologic cancers
BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
This study is testing a new support program to see if it can help people with advanced gastrointestinal and gynecologic cancers feel better and need less hospital care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06936878 on ClinicalTrials.gov |
What this trial studies
This research evaluates the BOLSTER Program, designed to assist patients with advanced gastrointestinal and gynecologic cancers who have complex care needs. The study is a multi-center, randomized trial aimed at improving the quality of life, alleviating symptoms, and reducing hospital care requirements for participants. It involves screening for eligibility, administering questionnaires, and conducting telehealth visits over a 12-week period. Approximately 300 patient-caregiver dyads will participate, with funding provided by the National Cancer Institute.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with advanced gastrointestinal or gynecologic cancers who have complex care needs.
Not a fit: Patients who do not have advanced cancer or do not require skilled care may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life for patients with advanced cancers and their caregivers.
How similar studies have performed: Other studies have shown promise in similar supportive care approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alexi Wright, MD MPH — Dana-Farber Cancer Institute
- Study coordinator: Alexi Wright, MD, MPH
- Email: alexi_wright@dfci.harvard.edu
- Phone: 617-632-2334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.