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

Dana-Farber Cancer Institute121 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

121

Conditions

Gynecologic Cancer Gastrointestinal Cancer

Interventions

BOLSTERBEHAVIORAL

BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.

Enhanced Discharge Planning (EDP)OTHER

EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patient inclusion criteria * Adults (≥18 years old); * GYN or GI cancers receiving anti-neoplastic therapy; * Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter); * Plan to receive ongoing care at DFCI; * Willingness to be audio taped for the study (for monitoring of study fidelity). * Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition) Patient exclusion criteria * Unable to read and respond to questions in English; * Cognitive impairment; * Unable to complete the baseline interview; * Plan for immediate hospice referral Caregiver inclusion criteria * Adults (≥18 years old); * Family member or friend of an eligible patient; * Willingness to be audio taped for the study (for monitoring of study fidelity); * Willingness to participate in study visits Caregiver exclusion criteria: * Unable to read and respond to questions in English, * Cognitive impairment * Unable to complete the baseline interview

Locations (1)

25873

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of the BOLSTER Intervention

≥50% consent-to-approach ratio

Time frame: 1 month

Secondary Outcomes

Acceptability of the BOLSTER Intervention

≥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.

Time frame: 3 months

Data from ClinicalTrials.gov

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