Clinical trial · Interventional
BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
NCT03367247CI-TRIAL-00105074completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BOLSTER | Behavioral | — | UNRESOLVED |
| Enhanced Discharge Planning (EDP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bolster
- description
- * Bolster provides participants with longitudinal nursing support across care settings, * A smartphone-based symptom management app, * A print and web-based symptom management toolkit, * Advance care planning to ensure that the patient receives care that is congruent with her informed preferences * BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks * Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice
- interventionNames
- Behavioral: BOLSTER
- type
- OTHER
- label
- Enhanced Discharge Planning (EDP)
- description
- * Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call
- interventionNames
- Other: Enhanced Discharge Planning (EDP)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPozzar RA, Enzinger AC, Poort H, Furey A, Donovan H, Orechia M, Thompson E, Tavormina A, Fenton ATHR, Jaung T, Braun IM, DeMarsh A, Cooley ME, Wright AA. Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis. J Palliat Med. 2022 Sep;25(9):1367-1375. doi: 10.1089/jpm.2021.0618. Epub 2022 Mar 17. PMID 35297744
- DERIVEDPozzar RA, Enzinger AC, Howard C, Tavormina A, Matulonis UA, Campos S, Liu JF, Horowitz N, Konstantinopoulos PA, Krasner C, Wall JA, Sciacca K, Meyer LA, Lindvall C, Wright AA. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial. Gynecol Oncol. 2024 Sep;188:1-7. doi: 10.1016/j.ygyno.2024.06.001. Epub 2024 Jun 7. PMID 38851039