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

NCT ID: NCT04340713

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-22
• Study Completion Date: 2020-02-29

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.

Conditions

Information Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Information support group

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

Group Type: EXPERIMENTAL

information support program

Intervention Type: OTHER

According to the established information support program for prostate cancer patients during hormonal therapy, information support and guidance on disease knowledge, symptom management, life care and other aspects are provided to patients through face-to-face communication, telephone, written information, network and other ways.

Routine care group

The control group was given routine information communication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

information support program

According to the established information support program for prostate cancer patients during hormonal therapy, information support and guidance on disease knowledge, symptom management, life care and other aspects are provided to patients through face-to-face communication, telephone, written information, network and other ways.

Intervention Type: OTHER

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.

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

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhenqi Lu

Director of Nusing Administration

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rui Yang

Shanghai, , China

Countries

China

Other Identifiers

IRB 1805185-14

Identifier Type: -

Identifier Source: org_study_id