search
Back to results

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

Primary Purpose

Information Support

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
information support program
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Information Support focused on measuring Prostate cancer; hormonal therapy; information support

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rui Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Information support group

Routine care group

Arm Description

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

The control group was given routine information communication.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mastery of disease knowledge
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.
Adherence of healthy behaviors
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.
Health-related quality of life
AMS, a questionnaire include 17 items was used to measure patients' somatic symptom, psychological symptom, sexual symptom, and patients' health-related quality of life.
the serum PSA level
The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention.

Full Information

First Posted
April 7, 2020
Last Updated
April 7, 2020
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04340713
Brief Title
The Effect of Information Support Program on Self-efficacy of Prostate Cancer Patients During Hormonal Therapy
Official Title
Construction and Evaluation of Supportive Care for Patients With Prostate Cancer During Hormonal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Information Support
Keywords
Prostate cancer; hormonal therapy; information support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information support group
Arm Type
Experimental
Arm Description
The experimental group was given information support program intervention on the basis of routine information communication.
Arm Title
Routine care group
Arm Type
No Intervention
Arm Description
The control group was given routine information communication.
Intervention Type
Other
Intervention Name(s)
information support program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Information satisfaction
Description
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.
Time Frame
3 months
Title
Self-efficacy
Description
SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mastery of disease knowledge
Description
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.
Time Frame
3 months
Title
Adherence of healthy behaviors
Description
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.
Time Frame
3 months
Title
Health-related quality of life
Description
AMS, a questionnaire include 17 items was used to measure patients' somatic symptom, psychological symptom, sexual symptom, and patients' health-related quality of life.
Time Frame
3 months
Title
the serum PSA level
Description
The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention.
Time Frame
3 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rui Yang
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs