Actively Recruiting
BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
Led by Dana-Farber Cancer Institute · Updated on 2026-04-28
600
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the BOLSTER Program, a supportive care approach designed to help people with advanced gynecological or gastrointestinal cancers who have new and complex care needs. This randomized trial aims to improve quality of life, reduce symptoms, ease burdens, and decrease hospital care for participants with these advanced cancers. The study is funded by the National Cancer Institute and includes about 300 patient-caregiver pairs. Participants in the study are randomly assigned to one of two groups. One group receives usual care, including standard oncology appointments and access to nurse and specialist visits, along with surveys at 6 and 12 weeks. The other group participates in the BOLSTER Program, which involves six telehealth sessions for patients and caregivers with a trained nurse, two additional sessions for caregivers, and access to a website with tailored educational materials. Both groups complete baseline visits and follow-up surveys at 6 and 12 weeks. Participants will be involved for about 12 weeks, during which they complete questionnaires and telehealth visits. The study includes screening for eligibility and collects information using surveys such as the Functional Assessment of Cancer Therapy-General (FACT-G) to measure quality of life changes at 6 and 12 weeks. Researchers will also assess symptom management, healthcare use, anxiety, depression, caregiver burden, and patient-caregiver activation. The study carefully tracks participants and caregivers through surveys and telehealth interactions to evaluate the program's impact.
CONDITIONS
Brief Title
BOLSTER: Learning New Skills to Thrive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient
- Diagnosed with advanced gastrointestinal cancer (including esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)
- Has a complex care need such as an ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, or wound VAC
- Plans to receive ongoing cancer treatment
- Has a family caregiver or friend willing to participate
- Able to speak and read English or Spanish
- Willing to be audio-recorded
- Has the cognitive and physical ability to participate in a 60-minute interview
- Family or caregiver aged 18 years or older involved in patient care
- Family or caregiver willing to participate in study visits and be audio-recorded
You will not qualify if you...
- Participant has cognitive impairments as determined by their oncologist
- Participant is planning to enroll in hospice
- Participant unable to complete baseline survey
- Adults unable to consent
- Individuals who are not adults (infants, children, teenagers)
- Prisoners
- Family or caregiver unable to complete baseline survey
- Family or caregiver adults unable to consent
- Family or caregiver individuals who are not adults (infants, children, teenagers)
- Family or caregiver prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Approximately 12 weeks
Participants randomized to the BOLSTER Program will engage in six telehealth sessions with a nurse and two additional brief telehealth sessions for care partners. Participants will also have access to a website with personalized educational materials to support their well-being.
8 telehealth sessions over 12 weeks
Duration - Approximately 12 weeks
Participants randomized to usual care complete baseline and follow-up assessments alongside standard oncology appointments and access to nurse and specialist care as part of routine healthcare.
1 baseline visit and 2 survey visits (at 6 and 12 weeks)
Trial Site Locations
Total: 2 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alexi Wright, MD, MPH
I
Irene Wang, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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