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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02809495
Other study ID # 1-2016
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 17, 2016
Last updated June 17, 2016
Start date June 2016
Est. completion date June 2018

Study information

Verified date June 2016
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: University of Sao Paulo, medical school
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms

  • the Focus of This Study is to Develop an Application for Postoperative Follow-up of Patients With Prostate Cancer

Intervention

Other:
use of app in smartphone


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate if the adherence of patients who use the application is greater after treatment 24 months No