BOLSTER: Learning New Skills to Thrive (NCT06936878) | Clinical Trial Compass
RecruitingNot Applicable
BOLSTER: Learning New Skills to Thrive
United States600 participantsStarted 2025-05-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 no…
What they're measuring
1
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
Timeframe: Baseline to 6 weeks post-discharge
2
Change in FACT-G Score From Baseline to Week 6 (Arm 2)