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A Support Program (BOLSTER) for the Improvement of Quality of Life in Metastatic Gynecologic or Gastrointestinal Cancer Patients with Complex Care Needs and their Caregivers, BOLSTER Trial
Trial Status: active
This clinical trial studies whether a support program, Building Out Lifelines for Safety, Trust, Empowerment, and Renewal (BOLSTER), improves quality of life (QOL) for patients that have a complex care need due to gynecologic or gastrointestinal (GI) cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and their caregivers. Gynecologic and GI cancer can cause complications that require surgery or other interventions to treat, such as placement of tubes, lines, drains, or an opening (a stoma) from an area inside the body to the outside (ostomy). Often people with cancer, and their close family members or friends who help them, are expected to perform new medical or nursing tasks at home that can feel overwhelming. This can lead them to need more help managing new care needs and symptoms at home. BOLSTER is a program that supports patients with new medical needs, such as tubes, lines, drains, or ostomies. The program consists of a dedicated nurse and educational materials that were designed to help people with new medical needs, and their loved ones, learn how to navigate this “new normal.” This may help patients and caregivers manage the new care needs and symptoms at home, which may improve QOL.
Inclusion Criteria
PATIENT: Age ≥ 18 years
PATIENT: Currently hospitalized or have acquired a skilled care need as an outpatient
PATIENT: Diagnosed with metastatic gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or metastatic gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar) cancer
PATIENT: Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound vacuum-assisted closure [VAC])
PATIENT: Plans to receive ongoing cancer treatment
PATIENT: Has a family caregiver or friend (hereafter designated family caregiver) willing to participate
PATIENT: Able to speak and read English or Spanish (self-report)
PATIENT: Are willing to be recorded (audio or video)
PATIENT: Have the cognitive/physical ability to participate in a 60-minute interview
FAMILY CAREGIVER: Age ≥ 18 years
FAMILY CAREGIVER: Identified by a patient (as defined above) as a family or friend who is involved in their care
FAMILY CAREGIVER: Willing to participate in study visits
FAMILY CAREGIVER: Willing to be recorded (audio or video)
Exclusion Criteria
PATIENT: Has cognitive impairments (as determined by the patient’s oncologist)
PATIENT: Planning to enroll in hospice
PATIENT: Unable to complete baseline survey
FAMILY CAREGIVER: Unable to complete baseline survey
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06936878.
I. To determine the effects of BOLSTER on patient QOL, as mediated by symptoms, self-efficacy for symptom management, and health care utilization.
II. To determine the effects of BOLSTER on family caregiver burden, distress, and self-efficacy for managing patient symptoms.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants receive usual care including follow-up visits with the oncology team and access to program nurses for 6 weeks.
ARM 2: Within 1 week after hospital discharge or acquiring a new complex care need, participants receive usual care plus six structured telehealth sessions with a BOLSTER nurse dedicated to discharge education, care coordination, skills training, symptom management, and coping and advance care planning once a week (QW) for 6 weeks. Caregivers also receive additional BOLSTER nurse telehealth sessions between sessions 2 and 3 and sessions 4 and 5. Additionally, participants receive access to a website with patient- and family-centered educational materials for specialized care needs on study.
After completion of study intervention, participants are followed up at 6- and 12-weeks post-discharge.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
