Navigator Guided e-Psychoeducational Intervention

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Personalized Health Information Navigator (PHIN); Other: NCI Information Booklets (IB)

• Registration Number: NCT02186444
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-02
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Primary Completion: 2016-12-30
• Status Verified: 2017-08
• Study Completion: 2017-08-17
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 391

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PHI Navigator	Personalized Health Information Navigator (PHIN)	Personalized Health Information Navigator (PHIN).
NCI Information Booklets (IB)	NCI Information Booklets (IB)	National Cancer Institute (NCI) Information Booklets (IB).

Primary Outcome Measures

Name	Time	Method
Final Survey Results per Study Arm	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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer and Research Institute; 🇺🇸 Tampa, Florida, United States