Overview
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.
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
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