BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers

ENROLLING
Protocol # :
24-523
Conditions
Gastrointestinal Cancer
Gynecologic Cancer
Advanced Cancer
Phase
III
Disease Sites
Gallbladder/Biliary
Esophagus
Stomach
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Cervix
Corpus Uteri
Ovary
Other Female Genital
Principal Investigator
Wright, Alexi, A

Trial Description

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.

Eligibility Requirements

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

24-523