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

Not Applicable

Completed

• Conditions: Gastrointestinal Cancer; Gynecologic Cancer

• Registration Number: NCT03367247
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).

The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2018-04-24
• Primary Completion: 2022-06-30
• Results First Submitted: 2023-06-15
• Study Completion: 2023-07-27
• Results First Submitted QC: 2023-07-27
• Results First Posted: 2023-08-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the BOLSTER Intervention	1 month	≥50% consent-to-approach ratio

Secondary Outcome Measures

Name	Time	Method
Acceptability of the BOLSTER Intervention	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.

Trial Locations

Locations (1)

25873; 🇺🇸 Boston, Massachusetts, United States