N/A
N=121
BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
Gynecologic Cancer · Gastrointestinal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03367247 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Feasibility of the BOLSTER Intervention — 73; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BOLSTER (Behavioral); Enhanced Discharge Planning (EDP) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the BOLSTER Intervention |
73; 22 | — |
| SECONDARY Acceptability of the BOLSTER Intervention |
14; 8; 6; 2; 2; 0 | — |
Summary
This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.
Eligibility Criteria
Patient inclusion criteria
- Adults (≥18 years old);
- GYN or GI cancers receiving anti-neoplastic therapy;
- Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter);
- Plan to receive ongoing care at DFCI;
- Willingness to be audio taped for the study (for monitoring of study fidelity).
- Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition)
Patient exclusion criteria
- Unable to read and respond to questions in English;
- Cognitive impairment;
- Unable to complete the baseline interview;
- Plan for immediate hospice referral
Caregiver inclusion criteria
- Adults (≥18 years old);
- Family member or friend of an eligible patient;
- Willingness to be audio taped for the study (for monitoring of study fidelity);
- Willingness to participate in study visits
Caregiver exclusion criteria:
- Unable to read and respond to questions in English,
- Cognitive impairment
- Unable to complete the baseline interview
Data sourced from ClinicalTrials.gov (NCT03367247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.