BOLSTER: Learning New Skills to Thrive (BOLSTER)

BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Advanced Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Behavioral: BOLSTER Program

Detailed Description

This multi-center, randomized trial is to test the efficacy of the BOLSTER Program and to improve participant quality of life (QOL), alleviate symptoms, reduce burden, and decrease the need for hospital care in participants with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers.

The research study procedures include screening for eligibility, questionnaires, and telehealth visits.

Participation in this research study is expected to last about 12 weeks.

About 300 dyads (patients with family caregivers) are expected to participate in this research study.

The National Cancer Institute is funding this research study by providing funding.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexi Wright, MD, MPH; Phone Number: 617-632-2334; Email: Alexi_Wright@dfci.harvard.edu
• Study Contact Backup: Name: Irene Wang, MPH; Phone Number: 617-582-7238; Email: irene_wang@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Alexi Wright, MD, MPH; Phone Number: 617-632-2334; Email: Alexi_Wright@dfci.harvard.edu
      • Principal Investigator: Alexi Wright, MD, MPH
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Contact: Larissa Meyer, MD; Phone Number: 713-745-0973; Email: lmeyer@mdanderson.org
      • Contact: Maria Iniesta-Donate, MD, PhD; Phone Number: 281-928-9892; Email: miniesta@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Participant Inclusion Criteria:

• 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

Family or Caregiver Inclusion Criteria:

• 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

Participant Exclusion Criteria:

• 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

Family or Caregiver Exclusion Criteria:

• Unable to complete baseline survey
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: Usual Care; Participants 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
Experimental: Arm 2: Bolster Program; Patients 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	Behavioral: BOLSTER Program; 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; Other Names: BOLSTER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FACT-G Score From Baseline to Week 12 (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 12 weeks post-discharge
Change in FACT-G Score From Baseline to Week 12 (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 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)	Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. 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 28. A higher score indicates better quality of life.	Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)	Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. 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 28. A higher score indicates better quality of life.	Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)	Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. 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 28. A higher score indicates better quality of life.	Baseline to 12 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)	Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. 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 28. A higher score indicates better quality of life.	Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)	Assessed by the Self-Efficacy for Managing Chronic Conditions - Short Form 4a, an 8-item measure for determining managements of symptoms and medications. Answers are rated on a 5-point Likert scale from 1 "I am not at all confident" to 5 "I am very confident" with a total scores range of 0 to 40. A higher score indicates greater self-efficacy.	Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)	Assessed by the Self-Efficacy for Managing Chronic Conditions - Short Form 4a, an 8-item measure for determining managements of symptoms and medications. Answers are rated on a 5-point Likert scale from 1 "I am not at all confident" to 5 "I am very confident" with a total scores range of 0 to 40. A higher score indicates greater self-efficacy.	Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)	Assessed by the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Care Needs and Managing Medications and Treatment. The Managing Care Needs (7 items) and Managing Medications and Treatment - Short Form 4a (6 items) evaluate confidence in handling medical care, including managing devices, medications, and symptoms. Responses are rated on a 5-point Likert scale from 1 ("Not at all confident") to 5 ("Very confident"), with higher scores indicating greater self-efficacy.	Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)	Assessed by the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Care Needs and Managing Medications and Treatment. The Managing Care Needs (7 items) and Managing Medications and Treatment - Short Form 4a (6 items) evaluate confidence in handling medical care, including managing devices, medications, and symptoms. Responses are rated on a 5-point Likert scale from 1 ("Not at all confident") to 5 ("Very confident"), with higher scores indicating greater self-efficacy.	Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 1)	Defined as the numeric value of the frequency of health care utilization by participant and collected by the Health Care Utilization Report, which is a log that covers the previous 12 weeks and collects emergency room visits, hospitalizations, and rehabilitation admissions.	Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 2)	Defined as the numeric value of the frequency of health care utilization by participant and collected by the Health Care Utilization Report, which is a log that covers the previous 12 weeks and collects emergency room visits, hospitalizations, and rehabilitation admissions.	Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)	ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.	Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)	ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.	Baseline to 12 weeks post-discharge
Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 12 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 12 weeks post-discharge
Caregiver Perception of Quality of End-of-Life Care	Caregiver perception of end-of-life care will be assessed through a validated after-death bereaved family interview, evaluating healthcare utilization, quality of care, symptom management, and goal attainment.	Up to 12 weeks
Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)	Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.	Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)	Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.	Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)	Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.	Baseline to 12 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)	Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.	Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)	Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.	Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)	Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.	Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)	The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.	Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)	The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.	Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)	The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.	Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)	The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.	Baseline to 12 weeks post-discharge

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alexi Wright, MD MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 13, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Cancer; Gastrointestinal Cancer; Gynecologic Cancer; Advanced Gastrointestinal Cancer; Advanced Gynecologic Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 24-523; R01CA270040-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No