Navigator Guided e-Psychoeducational Intervention

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).

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Health Information Navigator (PHIN)

Other

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)

Other

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.

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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Jul 10, 2014
Registry last updated: Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed