BOLSTER: Learning New Skills to Thrive

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Advanced Cancer; Gastrointestinal Cancer; Gynecologic Cancer

Treatments: Behavioral: BOLSTER Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06936878

24-523

R01CA270040-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Arm 1: Usual Care

No Intervention group

Description:

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

Arm 2: Bolster Program

Experimental group

Description:

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

Treatment:

Behavioral: BOLSTER Program