Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-05-12
2029-09-30
Brief Summary
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Detailed Description
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The research study procedures include screening for eligibility, questionnaires, and telehealth visits.
Participation in this research study is expected to last about 12 weeks.
About 300 dyads (patients with family caregivers) are expected to participate in this research study.
The National Cancer Institute is funding this research study by providing funding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm 1: Usual Care
Participants and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete:
* Baseline visit
* Standard-of-care oncology appointments
* Access to nurse and specialist appointments
* 6 week survey
* 12 week survey
No interventions assigned to this group
Arm 2: Bolster Program
Patients and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete:
* Baseline visit
* 6 telehealth sessions with a nurse for patients and their care partners
* 2 brief telehealth sessions for care partners.
* Access to the Bolster Program website with tailored educational materials
* 6 week survey
* 12 week survey
BOLSTER Program
This supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being
Interventions
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BOLSTER Program
This supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Planning to enroll in hospice
* Unable to complete baseline survey
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Unable to complete baseline survey
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Alexi A. Wright, MD
Principal Investigator
Principal Investigators
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Alexi Wright, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-523
Identifier Type: -
Identifier Source: org_study_id