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

Dana-Farber Cancer Institute

Status: Completed

Conditions: Gastrointestinal Cancer; Gynecologic Cancer

Treatments: Behavioral: BOLSTER; Other: Enhanced Discharge Planning (EDP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03367247

17-475

CA166210 (Other Grant/Funding Number)

R21CA223684 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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121 participants in 2 patient groups

Bolster

Experimental group

Description:

* 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

Treatment:

Behavioral: BOLSTER

Enhanced Discharge Planning (EDP)

Other group

Description:

* Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call

Treatment:

Other: Enhanced Discharge Planning (EDP)