BOLSTER: Learning New Skills to Thrive
BOLSTER
BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
2 other identifiers
interventional
600
1 country
2
Brief Summary
This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2025
CompletedFirst Posted
Study publicly available on registry
April 20, 2025
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
April 28, 2026
February 1, 2026
3.4 years
April 13, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Baseline to 6 weeks post-discharge
Change in FACT-G Score From Baseline to Week 6 (Arm 2)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Baseline to 6 weeks post-discharge
Secondary Outcomes (39)
Change in FACT-G Score From Baseline to Week 12 (Arm 1)
Baseline to 12 weeks post-discharge
Change in FACT-G Score From Baseline to Week 12 (Arm 2)
Baseline to 12 weeks post-discharge
Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)
Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)
Baseline to 12 weeks post-discharge
- +34 more secondary outcomes
Study Arms (2)
Arm 1: Usual Care
NO INTERVENTIONParticipants and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * Standard-of-care oncology appointments * Access to nurse and specialist appointments * 6 week survey * 12 week survey
Arm 2: Bolster Program
EXPERIMENTALPatients and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * 6 telehealth sessions with a nurse for patients and their care partners * 2 brief telehealth sessions for care partners. * Access to the Bolster Program website with tailored educational materials * 6 week survey * 12 week survey
Interventions
This supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient
- Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)
- Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)
- Plans to receive ongoing cancer treatment
- Has a family caregiver or friend (hereafter designated family caregiver) willing to participate
- Able to speak and read English or Spanish (self-report)
- Are willing to be audio-recorded
- Have the cognitive/physical ability to participate in a 60-minute interview
- Age ≥ 18 years
- Identified by a patient (as defined above) as a family or friend who is involved in their care.
- Willing to participate in study visits
- Willing to be audio recorded
You may not qualify if:
- Has cognitive impairments (as determined by the patient's oncologist)
- Planning to enroll in hospice
- Unable to complete baseline survey
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Unable to complete baseline survey
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexi Wright, MD MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2025
First Posted
April 20, 2025
Study Start
May 12, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
April 28, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.