The Effect of Information Support Program on Self-efficacy of Prostate Cancer Patients During Hormonal Therapy

Not Applicable

Completed

• Conditions: Information Support
• Interventions: Other: information support program

• Registration Number: NCT04340713
• Lead Sponsor: Fudan University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-11-22
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-29
• Status Verified: 2020-04
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Last Update Submitted: 2020-04-07
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 95

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information support group	information support program	The experimental group was given information support program intervention on the basis of routine information communication.

Primary Outcome Measures

Name	Time	Method
Self-efficacy	3 months	SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.
Information satisfaction	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 Outcome Measures

Name	Time	Method
Adherence of healthy behaviors	3 months	A self-designed questionnaire covering a total of 10 items was used to measure patients' adherence of healthy behaviors on the aspects of bad habits, diet, physical exercise, medication, and reviews.
the serum PSA level	3 months	The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention.
Mastery of disease knowledge	3 months	A self-designed questionnaire covering a total of 18 items was used to measure patients' knowledge on prostate cancer, review, hormonal therapy, and healthy life style.
Health-related quality of life	3 months	AMS, a questionnaire include 17 items was used to measure patients' somatic symptom, psychological symptom, sexual symptom, and patients' health-related quality of life.

Trial Locations

Locations (1)

Rui Yang; 🇨🇳 Shanghai, China