An interventional study of information support program in Information Support, sponsored by Fudan University. Completed at 1 site in China. Open to male participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by Fudan University · Not applicable, Interventional, and Supportive care
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 95 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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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.
The experimental group was given information support program intervention on the basis of routine information communication.
Other: information support program
The control group was given routine information communication.
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.
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.
Time frame: 3 months
Self-efficacy
SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
the serum PSA level
The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Fudan University