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

Primary Purpose

Gynecologic Cancer, Gastrointestinal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BOLSTER

Enhanced Discharge Planning (EDP)

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

25873

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bolster

Enhanced Discharge Planning (EDP)

Arm 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

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

Outcomes

Primary Outcome Measures

Feasibility of the BOLSTER Intervention

≥50% consent-to-approach ratio

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03367247

First Posted

November 28, 2017

Last Updated

October 7, 2023

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03367247

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

April 24, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Cancer, Gastrointestinal Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Outcomes Assessor

Masking Description

Clinical research assistant blinded to randomized study arms; will conduct structured interview at baseline, prior to randomization, and 4 weeks post randomization +/- 2 weeks.

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bolster

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Discharge Planning (EDP)

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

BOLSTER

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Enhanced Discharge Planning (EDP)

Intervention Description

EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

Primary Outcome Measure Information:

Title

Feasibility of the BOLSTER Intervention

Description

≥50% consent-to-approach ratio

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Acceptability of the BOLSTER Intervention

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexi A Wright, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

25873

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35297744

Citation

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.

Results Reference

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

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