Navigator Guided e-Psychoeducational Intervention

Navigator Guided e-Psychoeducational Intervention for Prostate Cancer Patients and Their Caregivers

The purpose of this study is to evaluate the impact of providing newly diagnosed prostate cancer patients and their caregivers with an interactive mobile tablet technology-based application delivered by a community navigator versus providing National Cancer Institute (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared decision making practices (decision making involvement).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Personalized Health Information Navigator (PHIN); Other: NCI Information Booklets (IB)

• Study Type: Observational
• Enrollment (Actual): 391

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients from Moffitt Cancer Center Genitourinary Clinic, University of South Florida Genitourinary Clinic, or community-based urologists and primary care providers.

Description

Inclusion Criteria:

• Men newly diagnosed (within 6 months) with biopsy confirmed case of prostate cancer
• 40 - 80 years of age
• Able to speak and read English
• Live within 120 miles of a healthcare treatment facility
• Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation
• Be able to complete telephone interviews
• Have not completed the first course of treatment
• Have a family member/caregiver willing to participate
• Capable of providing written consent for study participation. Men diagnosed with early stage, locally advanced or metastatic disease or men who are on active surveillance will be eligible to participate in this study.
• Caregiver must be aged 18 or older
• Caregiver must be identified by patient as their caregiver (i.e., provider of emotional and/or physical care)
• Caregiver must have not been diagnosed with cancer in the previous year or be receiving cancer treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PHI Navigator; Personalized Health Information Navigator (PHIN).	Other: Personalized Health Information Navigator (PHIN); The application (or "app") titled Personalized Health Information Navigator (PHIN) is an interactive psycho-educational intervention that will be delivered via mobile tablet technology. The PHIN provides patient-centered education. At the first meeting, the community navigator will provide a visual demonstration of PHIN on the Apple iPad. The community navigator will leave the iPad with the participant for 6-weeks and will stress the importance of using the PHIN app to address any educational or psychosocial needs.
NCI Information Booklets (IB); National Cancer Institute (NCI) Information Booklets (IB).	Other: NCI Information Booklets (IB); Participants will receive a packet of information booklets ("What You Need to Know About Prostate Cancer"; "Taking Time: Support for People with Cancer"; and "Facing Forward, Life After Cancer Treatment") that address prostate cancer treatment options, the late and long term effects, follow-up care, and sources of support. At the first meeting, the community navigator will provide a review of the print materials and stress the importance of reading the booklets carefully to help prepare for the discussion with your healthcare provider. The community navigator will leave the print materials with the participant for 6-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Survey Results per Study Arm	Investigators plan to assess if the psycho-educational intervention, PHIN, delivered by a CN is more efficacious as compared to NCI Information Booklets (IB) delivered by a CN. Participants will be asked to complete a baseline set of surveys and follow-up surveys at three additional time points: (1) 6 weeks after receiving the educational intervention; (2) after the follow-up decision with their doctor or health care provider; and (3) 6 months after the baseline surveys were done.	6 months post baseline survey

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: B. Lee Green, PhD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2014
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): August 17, 2017

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: prostate; newly diagnosed prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MCC-17455

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No