BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
Overview
- Phase
- N/A
- Intervention
- BOLSTER
- Conditions
- Gynecologic Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Feasibility of the BOLSTER Intervention
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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)
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:
Arms & Interventions
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
Intervention: BOLSTER
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
Intervention: Enhanced Discharge Planning (EDP)
Outcomes
Primary Outcomes
Feasibility of the BOLSTER Intervention
Time Frame: 1 month
≥50% consent-to-approach ratio
Secondary Outcomes
- Acceptability of the BOLSTER Intervention(3 months)