Redes III Patient Navigator Qol Study



Status:Completed
Conditions:Breast Cancer, Prostate Cancer, Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/4/2018
Start Date:November 2010
End Date:December 31, 2017

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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

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.

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.

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)
We found this trial at
2
sites
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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San Antonio, TX
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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