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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gynecologic Cancer, Gastrointestinal Cancer

Intervention / Treatment
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* Behavioral: BOLSTER
* Other: Enhanced Discharge Planning (EDP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Phase I: Single-arm study with up to 20 ovarian cancer patients and their informal caregivers run-in. Phase II: Two-arm pilot RCT with 60 gynecologic or gastrointestinal cancer patients and their informal caregivers (30 dyads in each arm).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolster<br>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 | Behavioral: BOLSTER<br>* BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.<br>|
| Other: Enhanced Discharge Planning (EDP)<br>Medication education, Self-management strategies for symptoms, Skills training, A list of red flag symptoms and numbers for who to call | Other: Enhanced Discharge Planning (EDP)<br>* EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the BOLSTER Intervention | ≥50% consent-to-approach ratio | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Bowel blockage, Ascites, Supportive care, Nursing, Mobile health, m-Health, Tele-health, Palliative Care, Symptom management, Gastrointestinal Cancer, Gynecologic Cancer, Complex Care Needs