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Clinical Trials/NCT02186444
NCT02186444
Completed
N/A

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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country391 target enrollmentJune 2, 2014
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
391
Locations
1
Primary Endpoint
Final Survey Results per Study Arm
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
June 2, 2014
End Date
August 17, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Male

Investigators

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Final Survey Results per Study Arm

Time Frame: 6 months post baseline survey

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.

Study Sites (1)

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