BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
- Conditions
- Gastrointestinal CancerGynecologic 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 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 Bolster BOLSTER * 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
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