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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367247
• Other study ID #: 17-475
• Secondary ID: CA166210R21CA223
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: July 27, 2023

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 27, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gynecologic Cancer

Intervention

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

Other:
• Enhanced Discharge Planning (EDP)
EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

Locations

Country	Name	City	State
United States	25873	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pozzar RA, Enzinger AC, Poort H, Furey A, Donovan H, Orechia M, Thompson E, Tavormina A, Fenton ATHR, Jaung T, Braun IM, DeMarsh A, Cooley ME, Wright AA. Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis. J Palliat Med. 2022 Sep;25(9):1367-1375. doi: 10.1089/jpm.2021.0618. Epub 2022 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the BOLSTER Intervention	=50% consent-to-approach ratio	1 month
Secondary	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