Status:
RECRUITING
BOLSTER: Learning New Skills to Thrive
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Cancer
Gynecologic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
This multi-center, randomized trial is to test the efficacy of the BOLSTER Program and to improve participant quality of life (QOL), alleviate symptoms, reduce burden, and decrease the need for hospit...
Eligibility Criteria
Inclusion
- Participant
- 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
- 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
- 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06936878
Start Date
May 12 2025
End Date
September 30 2029
Last Update
December 17 2025
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030