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

October 7, 2023 updated by: Alexi A. Wright, MD, Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • 25873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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)
  • 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)
EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the BOLSTER Intervention
Time Frame: 3 months
≥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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alexi A Wright, MD, MPH, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-475
  • CA166210 (Other Grant/Funding Number: NIH/NCI)
  • R21CA223684 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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