Navigator Guided e-Psychoeducational Intervention

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186444
• Other study ID #: MCC-17455
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: August 18, 2017
• Start date: June 2, 2014
• Est. completion date: August 17, 2017

Study information

• Verified date: August 2017
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: August 17, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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)
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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website