NCT03367247

BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal

Completed NA Results posted Last updated 10 March 2026

What this trial tests

NA trial testing BOLSTER in Gynecologic Cancer in 121 participants. Completed in 27 July 2023.

Timeline

24 April 2018

Primary endpoint
30 June 2022

27 July 2023

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	supportive care
Enrollment	121
Start date	24 April 2018
Primary completion	30 June 2022
Estimated completion	27 July 2023
Sites	1 location across United States

Drugs / interventions tested

• BOLSTER
• Enhanced Discharge Planning (EDP)

Conditions studied

• Gynecologic Cancer — all drugs for Gynecologic Cancer →
• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Gynecologic Cancer or Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of the BOLSTER Intervention Primary · 1 month

≥50% consent-to-approach ratio

Group	Value	95% CI
Patients Approached	73
Patients Approached	22

Acceptability of the BOLSTER Intervention Secondary · 3 months

≥70% participants "agree" or "strongly agree" that they would recommend BOLSTER to other patients; and ≥70% participants "agreed or "strongly agreed" that they were satisfied with the BOLSTER intervention. Note that this measure only includes data from the RCT portion of the study, as the Phases 1a and 1b were designed to refine the intervention.

Acceptability - "I have been satisfied with the BOLSTER program sessions..."

Group	Value	95% CI
Phase II (RCT): BOLSTER Arm Patients	14
Phase II (RCT): BOLSTER Arm Caregivers	8
Phase II (RCT): BOLSTER Arm Patients	6
Phase II (RCT): BOLSTER Arm Caregivers	2
Phase II (RCT): BOLSTER Arm Patients	2
Phase II (RCT): BOLSTER Arm Caregivers	0

Acceptability - "I would recommend the BOLSTER program to other patients..."

Group	Value	95% CI
Phase II (RCT): BOLSTER Arm Patients	16
Phase II (RCT): BOLSTER Arm Caregivers	8
Phase II (RCT): BOLSTER Arm Patients	5
Phase II (RCT): BOLSTER Arm Caregivers	2
Phase II (RCT): BOLSTER Arm Patients	1
Phase II (RCT): BOLSTER Arm Caregivers	0

Sponsor's own description

This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial.
   Pozzar RA, Enzinger AC, Howard C, Tavormina A, et al · · 2024 · cited 9× · PMID 38851039 · DOI 10.1016/j.ygyno.2024.06.001
2. Experiences of patients with peritoneal carcinomatosis-related complex care needs and their caregivers.
   Pozzar RA, Wall JA, Tavormina A, Thompson E, et al · · 2024 · cited 4× · PMID 38141533 · DOI 10.1016/j.ygyno.2023.12.013