BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
3 other identifiers
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedResults Posted
Study results publicly available
August 15, 2023
CompletedMarch 10, 2026
February 1, 2026
4.2 years
November 28, 2017
June 15, 2023
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of the BOLSTER Intervention
≥50% consent-to-approach ratio
1 month
Secondary Outcomes (1)
Acceptability of the BOLSTER Intervention
3 months
Study Arms (2)
Bolster
EXPERIMENTAL* 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
Enhanced Discharge Planning (EDP)
OTHER* Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call
Interventions
BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.
EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Unable to read and respond to questions in English;
- Cognitive impairment;
- Unable to complete the baseline interview;
- Plan for immediate hospice referral
- 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
- Unable to read and respond to questions in English,
- Cognitive impairment
- Unable to complete the baseline interview
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 35297744BACKGROUNDPozzar RA, Enzinger AC, Howard C, Tavormina A, Matulonis UA, Campos S, Liu JF, Horowitz N, Konstantinopoulos PA, Krasner C, Wall JA, Sciacca K, Meyer LA, Lindvall C, Wright AA. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial. Gynecol Oncol. 2024 Sep;188:1-7. doi: 10.1016/j.ygyno.2024.06.001. Epub 2024 Jun 7.
PMID: 38851039DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alexi Wright
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alexi A Wright, MD, MPH
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Clinical research assistant blinded to randomized study arms; will conduct structured interview at baseline, prior to randomization, and 4 weeks post randomization +/- 2 weeks.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 8, 2017
Study Start
April 24, 2018
Primary Completion
June 30, 2022
Study Completion
July 27, 2023
Last Updated
March 10, 2026
Results First Posted
August 15, 2023
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share