Clinical trial · Interventional
Redes III Patient Navigator Qol Study
Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program
- 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 proposed 5-year Redes En Acción research study involves a mixed-methods approach that occurs in two phases across two distinct and diverse HL communities. The RCT involves a 2 X 4 randomized repeated measures design with experimental condition (combined patient navigation \[PN\] over 3 months with access to LCNS PN services\[PNLCNS\] vs. a PN only condition) as the between-groups factor, and time-point (baseline/pre-randomization \[T1\]; post-PNLCNS \[about 3-months post-T1; T2\], and about 6- \[T3\] and about 12-months \[T4\] follow-up post-T2) as the within-groups factor; total follow-up is 15 months. The investigators will compare the effects of the PNLCNS and PN only conditions on QOL and treatment follow-up compliance in 300 (after attrition; n=100, Chicago and n=100, San Antonio) breast, colorectal and prostate HL cancer survivors with no evidence of metastatic disease.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PN+LCNC | Behavioral | — | UNRESOLVED |
| PN Only | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PN+LCNC
- description
- Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs. The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
- interventionNames
- Behavioral: PN+LCNC
- type
- ACTIVE_COMPARATOR
- label
- PN only
- description
- Patient Navigation ONLY. Participants assigned to this group will be assisted by the patient navigator with their health-related needs. Navigation will occur ONLY on contact with navigators initiated by the study participants.
- interventionNames
- Behavioral: PN Only
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Self identified Hispanic/Latino * At least 18 yrs old * Fluent in spoken Spanish or English * Diagnosed with breast, prostate or colorectal cancer within the past fifteen months and thus considered a cancer survivor and are currently not undergoing treatment, with the exception of hormone therapy for prostate patients * No evidence of metastatic disease * No current severe mental illness * No substance dependence within the past year - Exclusion Criteria: * Does not meet inclusion criteria * Psychotic Disorder * Active Suicidal Ideation * Substance dependence (alcohol/drugs) within the past 12 months * Does not meet the requisite cutoff of 3 or more correct responses on SPMSQ (Short Portable Mental Status Questionnaire)
References
Publications (1)
- DERIVEDNoriega Esquives BS, Moreno PI, Munoz E, Lad TE, Hollowell CMP, Benzo RM, Ramirez AG, Penedo FJ. Effects of a culturally tailored patient navigation program on unmet supportive care needs in Hispanic/Latino cancer survivors: A randomized controlled trial. Cancer. 2025 Jan 1;131(1):e35626. doi: 10.1002/cncr.35626. Epub 2024 Nov 1. PMID 39487386