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Digital Application Usage for Adherence of Patients Undergoing Robotic Assisted Radical Prostatectomy Following Oncological and Postoperative Functional Outcomes

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ClinicalTrials.gov Identifier: NCT02809495
Recruitment Status : Unknown
Verified June 2016 by University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
Prostate cancer (PC) is the most common non-skin tumor in men and the second leading cause of death from cancer in Brazil. It accounts for 13.8% of deaths from cancer in males, similar to what happens with breast cancer in females, corresponding to 15.8% of cancer deaths in women. Mobile applications, software developed for smartphones and tablets used for many different purposes (games, communication, entertainment etc) have become important tools of mHealth (Mobile Health in Portuguese - mobile health) as they allow remote support to patients or self-promotion of health care. It has been used globally to assist in the treatment and control of various diseases such as diabetes, physical inactivity, and many others. In oncology there are several applications developed to assist in the monitoring and treatment of various cancers such as gastric and breast cancer. So far it has not developed an application for follow-up of patients with PC, to capture data on satisfaction of post-treatment patient regarding the comorbidity of surgery, and also loyalty and adherence of patients to follow-up in offices allowing a possible intervention it is done at the right time. Nor was made compared to assess whether there is benefit in using this application. Thus, the objective of this work is to develop an application for smartphones facing the postoperative follow-up of patients undergoing robotic radical prostatectomy and compare adherence to treatment compared to accompanied by traditional way patient. In addition, we will evaluate the progress of the IPSS, ICIQ and IIEF-5 compared to preoperatively in patients undergoing prostatectomy robotic radical.

Condition or disease Intervention/treatment
the Focus of This Study is to Develop an Application for Postoperative Follow-up of Patients With Prostate Cancer Other: use of app in smartphone

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Digital Application Usage for Adherence of Patients Undergoing Robotic Assisted Radical Prostatectomy Following Oncological and Postoperative Functional Outcomes
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients who will use the clinical application Other: use of app in smartphone
Patients who do not make use of clinical application



Primary Outcome Measures :
  1. Evaluate if the adherence of patients who use the application is greater after treatment [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a prospective randomized controlled trial. We will select prospectively 100 patients diagnosed with prostate cancer. These patients will be divided into two groups using randomisation tables (www.random.org), which are: 1. Patients who will use the clinical application (n = 50) 2. Patients who do not use the application (n = 50 - group control).
Criteria

Inclusion Criteria:

  • patients having a diagnosis of prostate cancer who are undergoing robotic radical prostatectomy for treatment of the disease and who accept to participate in the study by signing the informed consent term.

Exclusion Criteria:

  • Patients who refused to participate in the study

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02809495     History of Changes
Other Study ID Numbers: 1-2016
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided