Recruiting

BOLSTER

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06936878

Conditions

Gastrointestinal Cancer

Gynecologic Cancer

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BOLSTER Program

Study Details

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 or gastrointestinal cancer and new and complex care needs.

Conditions

Gastrointestinal Cancer

Gynecologic Cancer

Advanced Cancer

Study ID

NCT06936878

Start date

May 12, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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

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 ]
  • Change in FACT-G Score From Baseline to Week 6 (Arm 2) [ Time Frame: Baseline to 6 weeks post-discharge ]

Central Contacts and Locations

Central contacts

Alexi Wright, MD, MPH

617-632-2334alexi_wright@dfci.harvard.edu

Irene Wang, MPH

617-582-7238irene_wang@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alexi Wright, MD, MPH

617-632-2334Alexi_Wright@dfci.harvard.edu

Principal Investigator:

Alexi Wright, MD, MPH

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Larissa Meyer, MD

713-745-0973lmeyer@mdanderson.org

Maria Iniesta-Donate, MD, PhD

281-928-9892miniesta@mdanderson.org

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Advanced Cancer
  • Advanced Gastrointestinal Cancer
  • Advanced Gynecologic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-06-18.