Navigator Guided e-Psychoeducational Intervention

NCT ID: NCT02186444

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 391 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-02
• Study Completion Date: 2017-08-17

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).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PHI Navigator

Personalized Health Information Navigator (PHIN).

Personalized Health Information Navigator (PHIN)

Intervention Type: 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)

National Cancer Institute (NCI) Information Booklets (IB).

NCI Information Booklets (IB)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B. Lee Green, PhD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-17455

Identifier Type: -

Identifier Source: org_study_id