Program to support patients with advanced gastrointestinal and gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the BOLSTER Program, designed to assist patients with advanced gastrointestinal and gynecologic cancers who have complex care needs. The study is a multi-center, randomized trial aimed at improving the quality of life, alleviating symptoms, and reducing hospital care requirements for participants. It involves screening for eligibility, administering questionnaires, and conducting telehealth visits over a 12-week period. Approximately 300 patient-caregiver dyads will participate, with funding provided by the National Cancer Institute.

Why it matters

Who can join: the full rules

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

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Alexi Wright, MD MPH — Dana-Farber Cancer Institute
• Study coordinator: Alexi Wright, MD, MPH
• Email: alexi_wright@dfci.harvard.edu
• Phone: 617-632-2334

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.