Information Support Clinical Trial
Official title:
Construction and Evaluation of Supportive Care for Patients With Prostate Cancer During Hormonal Therapy
| Verified date | April 2020 |
| Source | Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 95 |
| Est. completion date | February 29, 2020 |
| Est. primary completion date | January 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Rui Yang | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Fudan University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3 months | |
| Primary | Self-efficacy | SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping. | 3 months | |
| Secondary | 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. | 3 months | |
| Secondary | 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. | 3 months | |
| Secondary | 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. | 3 months | |
| Secondary | the serum PSA level | The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention. | 3 months |