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Redes III Patient Navigator Qol Study

NCT02275754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-10-02

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

PN+LCNC

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.

BEHAVIORAL

PN Only

Participants will be navigated by PN on request

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Amelie G Ramirez, DrPH · The University of Texas Health Science Center at San Antonio

  • Frank Penedo, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-09-30
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275754 on ClinicalTrials.gov