BOLSTER: Learning New Skills to Thrive

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer; Gynecologic Cancer; Advanced Cancer

• Registration Number: NCT06936878
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-13
• Study First Posted: 2025-04-20
• Status Verified: 2025-05
• Study Start: 2025-05-12
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in FACT-G Score From Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.

Secondary Outcome Measures

Name	Time	Method
Change in FACT-G Score From Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in FACT-G Score From Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
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	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.
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Health Care Utilization from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Health Care Utilization from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Caregiver Perception of Quality of End-of-Life Care	Up to 12 weeks	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.
Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)	Baseline to 6 weeks post-discharge	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.
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)	Baseline to 12 weeks post-discharge	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.
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)	Baseline to 12 weeks post-discharge	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.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States