CClinicalTrials.gg
CompletedNCT02275754Updated Oct 2, 2018

Redes III Patient Navigator Qol Study

An interventional study of PN+LCNC and PN Only in Breast Cancer, Prostate Cancer and Colorectal Cancer, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Hispanic/Latinos (HL) are the largest and fastest-growing minority population in the nation. HLs generally have lower survival rates for most cancers, even after accounting for differences in age and stage distribution, which may reflect less access to timely, high-quality treatment. They also experience disproportionately higher health disparities in quality of care and access to care. The experience of cancer survivorship is often characterized by significant challenges. Despite these challenges and significant disparities observed among HLs, there is very limited knowledge of survivorship-related issues and priorities among HLs, specifically the effectiveness of using promotores/patient navigators (PN) in linking HL cancer survivors with unmet psychosocial needs to appropriate psychosocial services. The existing community-based infrastructure of the Lance Armstrong Foundation (LAF) LIVESTRONG Cancer Navigation Services (LCNS) PN program provides an excellent opportunity to evaluate its efficacy in improving QOL among HLs. 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. Phase I will use a community-based participatory research (CBPR) approach to engage community-based partners that provide services to breast, colorectal and prostate HL cancer survivors. In this phase, the investigators will gather community partners for action-oriented group meetings at each site to present components and targets of the combined PN and LCNS PN program (PNLCNS). Through this CBPR approach to generate valuable community feedback, the investigators will enhance the role of the PN, develop and extend existing cooperative relationships to facilitate participant recruitment, and prepare community-based partners to disseminate and implement the PNLCNS program upon the established efficacy of the proposed randomized controlled trial (RCT) of Phase II. Phase II will test a RCT to evaluate the efficacy of a culturally tailored PNLCNS program on improving general and disease-specific quality of life (QOL) and treatment follow-up compliance among breast, colorectal and prostate HL cancer survivors. Phase II also will evaluate the extent to which intervention-associated improvements in these outcomes are mediated by targets of the PNLCNS program (e.g., communication with medical team, meeting unmet needs and improving health behaviors). 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. To understand the mechanisms by which the PNLCNS significantly impacts QOL and treatment compliance outcomes, the investigators also will examine changes in unmet cancer needs, communication with the medical team, health behaviors, psychological distress, worry, coping and general self-efficacy as potential mediators of the intervention effects. The investigators will also evaluate the extent to which other factors such as preparation for consultation (i.e., medical visit) and satisfaction with cancer care are associated with our QOL and treatment follow-up compliance outcomes. Study findings will fill a significant gap in our understanding of the extent to which PN programs and existing community-based resources targeting survivors can improve the QOL of a growing number of HL cancer survivors who experience an unequal burden of unmet needs after cancer treatment. The efficacy of the proposed RCT will provide a conceptually sound and clinically relevant approach to address the needs of HL cancer survivors by integrating evidence-based practice into existing community resources and infrastructure, thus facilitating the dissemination and translation of study findings through Phase I's CBPR process.

02

Conditions studied

  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer

Browse trials for

03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 300 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    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+LCNC

  • Active comparator
    PN only

    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.

    Behavioral: PN Only

Interventions

  • BehavioralPN+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.

  • BehavioralPN Only

    Participants will be navigated by PN on request

06

What researchers measure

Primary outcomes

  1. General quality of life

    The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to evaluate general domains of QOL. The FACT-G, now in its fourth revision, is one of the most widely used instruments to assess overall adjustment to cancer treatment and survivorship. It is a 27-item self-report questionnaire that takes less than 15 minutes to administer. The FACT-G assesses QOL in four domains of well-being: physical, social/family, emotional and functional well-being. Patients are asked to indicate the extent to which they agree with statements such as "I have pain," "I feel ill," "I get emotional support from my family," "I get support from my friends," "I feel sad," "I feel nervous," "I am sleeping well," and "I am content with the quality of my life right now." The scale is validated for use in many settings with many age groups. We will calculate a composite score for general QOL as well as subscale scores for specific domains of QOL.

    Time frame: 15 months

  2. Disease specific quality of life

    We will administer three cancer-specific FACT versions, the FACT-B (breast cancer survivors), FACT-C (colorectal cancer survivors) or FACT-P (prostate cancer survivors). Each version addresses QOL issues that are common sequelae of that certain cancer. For example, the FACT-P evaluates concerns on sexuality, pain, and bowel and bladder function, the FACT-C asks questions about bowel movement control, weight loss and cramping in the abdominal area, and the FACT-B inquires about hair loss, shortness of breath and swelling in the arms. Reliability of the FACT-G, as well as all cancer site-specific FACT measures are acceptable (Cronbach's α\>.70). Composite scores for disease-specific QOL will be calculated across each cancer site. Cancer site specific modules scores are standardized and can be combined across cancer sites.

    Time frame: 15 months

  3. Treatment Follow-up compliance

    Because all of our HL cancer survivors will be recruited within 12-months post-treatment completion for a primary tumor, we will follow ACS guidelines for follow-up care for one- to two-years post-treatment. We will assess via self-report whether the participant missed a scheduled follow-up appointment during the study period. A compliance categorical outcome measure (compliant vs. non-compliant) will be calculated for each participant. Compliance will be defined as attending all scheduled follow-up appointments specific to cancer treatment follow-up during the study period.

    Time frame: 15 months

07

Study locations

2 sites
  • Northwestern University
    Chicago, Illinois 60201, United States
  • The University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02275754
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 27, 2014
Start date
Nov 2010
Primary completion
Sep 2015
Completion
Dec 31, 2017
Last update
Oct 2, 2018

Study contacts

Amelie G Ramirez, DrPH
principal investigator · The University of Texas Health Science Center at San Antonio
Frank Penedo, PhD
study director · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion