BOLSTER: Learning New Skills to Thrive

Last updated: February 27, 2026
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Stomach Cancer

Vaginal Cancer

Treatment

BOLSTER Program

Clinical Study ID

NCT06936878
24-523
R01CA270040-01A1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Participant Inclusion Criteria:

  • Age ≥18 years

  • Currently hospitalized with skilled care need or have acquired a new skilled careneed 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, biliarydrain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, woundVAC)

  • Plans to receive ongoing cancer treatment

  • Has a family caregiver or friend (hereafter designated family caregiver) willing toparticipate

  • 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 intheir care.

  • Willing to participate in study visits

  • Willing to be audio recorded

Exclusion

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

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: BOLSTER Program
Phase:
Study Start date:
May 12, 2025
Estimated Completion Date:
February 29, 2028

Study 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 hospital care in participants with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers.

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.

Connect with a study center

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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