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

Not Applicable
Completed
Conditions
Gastrointestinal Cancer
Gynecologic Cancer
Interventions
Other: Enhanced Discharge Planning (EDP)
Behavioral: BOLSTER
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.

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
Arm && Interventions
GroupInterventionDescription
Enhanced Discharge Planning (EDP)Enhanced Discharge Planning (EDP)* Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call
BolsterBOLSTER* Bolster provides participants with longitudinal nursing support across care settings, * A smartphone-based symptom management app, * A print and web-based symptom management toolkit, * Advance care planning to ensure that the patient receives care that is congruent with her informed preferences * BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks * Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice
Primary Outcome Measures
NameTimeMethod
Feasibility of the BOLSTER Intervention1 month

≥50% consent-to-approach ratio

Secondary Outcome Measures
NameTimeMethod
Acceptability of the BOLSTER Intervention3 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

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