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Clinical Trials/NCT04340713
NCT04340713
Completed
Not Applicable

Construction and Evaluation of Supportive Care for Patients With Prostate Cancer During Hormonal Therapy

Fudan University1 site in 1 country95 target enrollmentNovember 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Information Support
Sponsor
Fudan University
Enrollment
95
Locations
1
Primary Endpoint
Self-efficacy
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The incidence rate of prostate cancer has been increasing rapidly in China in recent years. However, a large number of studies have shown that, patients with prostate cancer during hormonal therapy generally face the imbalance of high information demand and low information acquisition, which affects their mental health and quality of life, and even reduces their treatment adherence. Thus, the investigators designed a randomized control study in one cancer center in Shanghai. Prostate cancer patients during hormonal therapy were followed up in the urology clinic and ward, and then they were randomly divided into control group and experimental group according to the order of enrollment. The control group was given routine information communication, and the experimental group was given information support program intervention on this basis. The effects of the intervention was evaluated after 3 months. The investigators expected that the information support program would be helpful to improve patients' self-efficacy level, and to enhance their confidence in self-management and coping with difficulties, so as to improve patients' adherence of health behaviors and improve their health-related quality of life.

Detailed Description

The incidence rate of prostate cancer has been increasing rapidly in China in recent years. It has gradually become one of the most common malignant tumors of the urinary system in men. However, a large number of studies have shown that, patients with prostate cancer during hormonal therapy generally face the imbalance of high information demand and low information acquisition, which affects their mental health and quality of life, and even reduces their treatment adherence. Thus, the investigators designed a randomized control study in one cancer center in Shanghai. Prostate cancer patients during hormonal therapy were followed up in the urology clinic and ward of a cancer center in Shanghai from July to October 2019 ,then patients were randomly divided into control group and experimental group according to the order of enrollment. The control group was given routine information communication, and the experimental group was given information support program intervention on this basis. The effects of the intervention was evaluated after 3 months. The investigators expected that the information support program would be helpful to improve patients' self-efficacy level, and to enhance their confidence in self-management and coping with difficulties, so as to improve patients' adherence of health behaviors and improve their health-related quality of life.

Registry
clinicaltrials.gov
Start Date
November 22, 2018
End Date
February 29, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhenqi Lu

Director of Nusing Administration

Fudan University

Eligibility Criteria

Inclusion Criteria

  • Patients were diagnosed as prostate cancer by biopsy or operation; At the initial stage of hormonal therapy for prostate cancer (0-3 months); The time of hormonal therapy was expected more than 6 months; Master basic operation skills of the app "wechat", or can simply use it after learning; Primary school education or above; Age \< 80; Have a clear sense of reading, understanding and communication skills; Willing to participate in this study and sign informed consent.

Exclusion Criteria

  • Have received castration operation; Combined with other tumors; Combined with other serious endocrine diseases; Serious diseases in heart, brain, lung or other important organs.

Outcomes

Primary Outcomes

Self-efficacy

Time Frame: 3 months

SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.

Information satisfaction

Time Frame: 3 months

EORTC QLQ-INFO25, a questionnaire include 25 items was used to measure patients' information acquisition and information satisfaction on disease, medical tests, treatments, and other aspects.

Secondary Outcomes

  • Adherence of healthy behaviors(3 months)
  • the serum PSA level(3 months)
  • Health-related quality of life(3 months)
  • Mastery of disease knowledge(3 months)

Study Sites (1)

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