Clinical trial · Interventional
BOLSTER: Learning New Skills to Thrive
BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
NCT06936878CI-TRIAL-00115321BOLSTERrecruitingN/AClinicalTrials.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 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BOLSTER Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm 1: Usual Care
- description
- Participants and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * Standard-of-care oncology appointments * Access to nurse and specialist appointments * 6 week survey * 12 week survey
- type
- EXPERIMENTAL
- label
- Arm 2: Bolster Program
- description
- Patients and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * 6 telehealth sessions with a nurse for patients and their care partners * 2 brief telehealth sessions for care partners. * Access to the Bolster Program website with tailored educational materials * 6 week survey * 12 week survey
- interventionNames
- Behavioral: BOLSTER Program
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.