Information SupportNCT04340713
The Effect of Information Support Program on Self-efficacy of Prostate Cancer Patients During Hormonal Therapy
A study testing information support program in people with Information Support, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Information Support
- What is being tested?
- information support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2018to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have received castration operation; Combined with other tumors; Combined with other serious endocrine diseases; Serious diseases in heart, brain, lung or other important organs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction and Evaluation of Supportive Care for Patients With Prostate Cancer During Hormonal Therapy
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.
Read the 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
- Being tested
- information support program
- Keywords
- Prostate cancer; hormonal therapy; information support
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
information support programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Information support group | Experimental | The experimental group was given information support program intervention on the basis of routine information communication. Receives: Other: information support program |
| Routine care group | No intervention | The control group was given routine information communication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Self-efficacy
SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
the serum PSA level
The serum PSA (prostate cancer specific antigen) level was recorded at baseline and 3 months after intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start22 Nov 2018
- Primary completion31 Jan 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information SupportStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenqi Lu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340713
- Sponsor's protocol ID
- IRB 1805185-14
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of Supportive Care for Patients With Prostate Cancer During Hormonal Therapy
- ClinicalTrials.gov ID
- NCT04340713
- Acronym / sponsor ID
- IRB 1805185-14
- Conditions
- Information Support
- Keywords
- Prostate cancer; hormonal therapy; information support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information support group | Experimental | Other: information support programThe experimental group was given information support program intervention on the basis of routine information communication. |
| Routine care group | No intervention | –The control group was given routine information communication. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Have received castration operation; Combined with other tumors; Combined with other serious endocrine diseases; Serious diseases in heart, brain, lung or other important organs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| information support programAccording 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. | Other | Information support group |
Primary outcome
Information satisfaction
Time frame: 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.
Self-efficacy
Time frame: 3 months
SUPPH, the Chinese version include 28 items was used to measure patients' level of self-efficacy and confidence in coping.
4 secondary outcomes
Mastery of disease knowledge
Time frame: 3 months
Adherence of healthy behaviors
Time frame: 3 months
Health-related quality of life
Time frame: 3 months
the serum PSA level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing information support program in people with Information Support, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information satisfaction (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.