Clinical trial NCT06936878: BOLSTER: Learning New Skills to Thrive
Official title: BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Gynecologic Cancer
Advanced Cancer
Keywords: Gastrointestinal Cancer
Gynecologic Cancer
Advanced Cancer
Advanced Gastrointestinal Cancer
Advanced Gynecologic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in FACT-G Score From Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
Secondary outcomes:
measure: Change in FACT-G Score From Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in FACT-G Score From Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Health Care Utilization from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Health Care Utilization from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Caregiver Perception of Quality of End-of-Life Care
timeFrame: Up to 12 weeks
measure: Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)
timeFrame: Baseline to 6 weeks post-discharge
measure: Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)
timeFrame: Baseline to 12 weeks post-discharge
measure: Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)
timeFrame: Baseline to 12 weeks post-discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi Wright, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: