Redes III Patient Navigator Qol Study

NCT02275754 | Completed DMC

• 2 other identifiers: HSC20110094HU54CA153511
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer; Prostate Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  15 months

• 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.

  15 months

• 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.

  15 months

Study Arms (2)

PN+LCNC

EXPERIMENTAL

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

PN only

ACTIVE COMPARATOR

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

PN+LCNC BEHAVIORAL

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.

PN+LCNC

PN Only BEHAVIORAL

Participants will be navigated by PN on request

PN only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60201, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Noriega 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Amelie G Ramirez, DrPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Frank Penedo, PhD

  Northwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: October 27, 2014
• Study Start: November 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: December 31, 2017
• Last Updated: October 2, 2018

Record last verified: 2017-09

Locations

US (2)