BOLSTER: Learning New Skills to Thrive

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06936878
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Gastrointestinal Cancer
  • Gynecologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BOLSTER Program — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
May 12, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: 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
  • Experimental: 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

Primary Outcome Measure

Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1) [ Time Frame: Baseline to 6 weeks post-discharge ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alexi Wright, MD, MPH
[email protected]
617-632-2334
Alexi Wright, MD, MPH (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Larissa Meyer, MD
[email protected]
713-745-0973
Maria Iniesta-Donate, MD, PhD
[email protected]
281-928-9892

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAThe University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies