Clinical trial · Interventional
A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care
NCT05488444CI-TRIAL-00081834withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 0 Participants Accrued
Summary
Brief summary (as posted)
Project Lets start will provide individual support to breast cancer patients with the goal of reducing delay to chemotherapy initiation. In this study participants will identify areas of need and work with patient navigators who will provide weekly 1-1 support throughout patient's journey to beginning chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exit Interview | Behavioral | — | UNRESOLVED |
| Navigator Phone Calls | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (Investigational Group)
- description
- Participants will complete an in-depth patient needs checklist to identify patient-specific barriers that could lead to a delay with starting chemotherapy.
- interventionNames
- Behavioral: Navigator Phone Calls
- Behavioral: Exit Interview
- type
- EXPERIMENTAL
- label
- Group 2 (Control Group)
- description
- Participants will follow routine clinical care, where chemotherapy start date is determined by the provider and patient.
- interventionNames
- Behavioral: Navigator Phone Calls
- Behavioral: Exit Interview
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: I. At least 18 years of age. II. Diagnosis of primary invasive breast cancer. III. Chemotherapy (adjuvant or neo-adjuvant) recommended by treating physician (including pregnant women in 2nd or 3rd trimester). IV. Patient of the University of Texas MD Anderson Cancer Center or planning on receiving treatment at our Institution. V. Can speak, read, and understand English and/or Spanish. VI. Participant can provide consent for themself Exclusion Criteria: I. Hospitalized for a critical condition or who are considered medically unstable by their medical team. II. Patients that have been previously treated with chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.