Prostate CancerNCT05613881
Symptom Management, Education and Telephone Follow-up, Quality of Life,
A study testing Education and Telephone Follow-up in people with Prostate Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as an experimental design study with pretest-posttest control group in order to determine the effects of education and telephone follow-up given to patients receiving androgen deprivation therapy (ADT) for prostate cancer on quality of life and symptom management.The main question[s] it aims to… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Education and Telephone Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 1 Dec 2022
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the research,
- Literate and open to communication,
- Knowing the diagnosis,
- Those aged 45 and over,
- Receiving short-term or long-term ADT treatment,
- The patient or his/her relatives have telephone access,
Who cannot join
- Having a mental or psychiatric illness that prevents communication,
- Those with vision-hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education and Telephone Follow-up on Quality of Life and Symptom Management in Patients Receiving Androgen Deprivation Therapy
This study was planned as an experimental design study with pretest-posttest control group in order to determine the effects of education and telephone follow-up given to patients receiving androgen deprivation therapy (ADT) for prostate cancer on quality of life and symptom management.The main question[s] it aims to answer are:
- Is the quality of life higher in patients receiving androgen deprivation therapy who are trained and followed up over the phone compared to patients who are only given an education booklet?
- Is symptom management higher in patients receiving androgen deprivation therapy who received training and followed-up over the phone compared to patients who were only given an education booklet?
Read the detailed description
The number of samples to be taken in each group was determined as 24 (total 48) with the help of the G-power (version 3.1) package program. Considering the possible losses in the research and in order to increase the power of the study, it was planned to carry out the research with a total of 60 people, 30 people in the experimental and control groups.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
- Conditions
- Prostate Cancer
- Being tested
- Education and Telephone Follow-up
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Telephone Follow-up, Nursing Education
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Telephone Follow-upOther
The individuals in this group will be given an education and training booklet by the researcher after the pre-tests are applied in the first face-to-face interview. After the first meeting, the individual will be called every 15 days, 5 times in total for 3 months, and the training will be repeated in line with the individual's needs. After 3 months, the final tests will be applied.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | the group to be trained and then monitored by phone Receives: Other: Education and Telephone Follow-up |
| CONTROL GROUP | No intervention | The individuals in this group will be given only education booklet by the researcher after the pre-tests are applied in the first face-to-face interview. 3 months after the first interview, the final tests will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
It is a questionnaire to measure quality of life which consists of three parts, namely "General Health Status Scale", "Functional Scale", "Symptom Scale" and a total of 30 questions. The last two questions (29,30); provides an assessment of the global quality of life. Each item in the scale is evaluated between 0 and 100 points. For each of the 28 questions in the functional scale and symptom scale, there are four options as none (1 point), a little (2 points), quite (3 points), a lot (4 points). On the general health scale, there are options ranging from very bad to excellent in the range of 1-7 points. Higher values represent a better situation
Measured: Through study completion, an average of 3 months
EORTC QLQ-PR25 Prostate Module
It is a questionnaire to measure quality of life and consisting of 25 items. Prostate Cancer-specific side effects related to surgery, radiotherapy or hormonal therapy that are not in QLQ-C30; voiding problems, bowel functions, sexual status. It consists of two functional (sexual activity and sexual function) and four symptom scales (urinary, intestinal, hormone therapy-related symptoms and incontinence). The score of each item in the scale is evaluated by converting it into a linear range of 0 to 100 points. For each of the 25 questions in the module, there are four options: none (1 point), a little (2 points), quite (3 points), a lot (4 points). A high score from the functional scale indicates a high functional level, and a high score from the symptom scale indicates that the symptoms are experienced intensely.
Measured: Through study completion, an average of 3 months
Secondary outcomes (8)
The blood pressure measurements
Blood pressure monitoring will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Blood pressure measurement is performed by the researcher using the same manual sphygmomanometer instrument during pretest and posttest data collection. Blood pressure is expressed in "mmHg".
Measured: 3 months
The heart rate measurement
Heart rate monitoring will be used to evaluate metabolic and cardiovascular risk factors, whichis side effect of ADT. The heart rate is measured by the researcher by counting over the radial artery for one minute during pretest and posttest data collection. Heart rate refers to the number of beats per minute.
Measured: 3 months
Weight
Weight monitoring will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Weight measurement is performed by the researcher using the wall weight meter during pretest and posttest data collection. Weight is expressed in "kilograms".
Measured: 3 months
Height
Height monitoring will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Height measurement is performed by the researcher using wall height meter during pretest and posttest data collection. Height is expressed in "meters".
Measured: 3 months
BMI
BMI monitoring will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Weight and height will be combined to report BMI in kg/m^2.
Measured: 3 months
Waist/Hip circumference measurement
Waist/Hip circumference measurement will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Waist circumference/hip circumference is measured with a plastic flexible tape measure while the patient is standing in an upright position. Waist/Hip circumference measurement is expressed in "centemeter".
Measured: 3 months
Prostate Spesific Antigen (PSA)
Prostate Specific Antigen (PSA) parameter will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Prostate Specific Antigen (PSA) will be obtained from the hospital automation system during pretest and posttest data collection. PSA is expressed in "(nanogram/milliliter) ng/ml".
Measured: 3 months
Glucose level
Glucose levels parameter will be used to evaluate metabolic and cardiovascular risk factors, which is side effect of ADT. Glucose level will be obtained from the hospital automation system during pretest and posttest data collection. Glucose level is expressed in "(milligram/deciliter) mg/dl".
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 posted14 Nov 2022
- Study start15 May 2022
- Primary completion15 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Experimental and control groups will be formed by randomization from individuals who meet the inclusion criteria. At the beginning of the research, a pre-test will be applied to both groups at the first interview. The individuals in the experimental group will be given an education and training booklet prepared in line with the literature by the researcher at the first interview. Only the training booklet will be given to the control group. Individuals in the experimental group will be called every 15 days for 3 months, in line with the Telephone Monitoring Instruction Form, to be interviewed and monitored. At the end of the 3rd month, the final tests will be applied. Individuals in the control group will be given post-tests at the end of the 3rd month..
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Ayfer ÖZBAŞ
- Responsible party
- Principal investigator, Tuğba Sınmaz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613881
- Sponsor's protocol ID
- E-74555795-050.01.04-185078
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Follow-up on Quality of Life and Symptom Management in Patients Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT05613881
- Acronym / sponsor ID
- E-74555795-050.01.04-185078
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Telephone Follow-up, Nursing Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Prof. Dr. Ayfer ÖZBAŞ
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Nov 2022 (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.
This study was planned as an experimental design study with pretest-posttest control group in order to determine the effects of education and telephone follow-up given to patients receiving androgen deprivation therapy (ADT) for prostate cancer on quality of life and symptom management.The main question[s] it aims to answer are:
- Is the quality of life higher in patients receiving androgen deprivation therapy who are trained and followed up over the phone compared to patients who are only given an education booklet?
- Is symptom management higher in patients receiving androgen deprivation therapy who received training and followed-up over the phone compared to patients who were only given an education booklet?
Detailed description
The number of samples to be taken in each group was determined as 24 (total 48) with the help of the G-power (version 3.1) package program. Considering the possible losses in the research and in order to increase the power of the study, it was planned to carry out the research with a total of 60 people, 30 people in the experimental and control groups.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental and control groups will be formed by randomization from individuals who meet the inclusion criteria. At the beginning of the research, a pre-test will be applied to both groups at the first interview. The individuals in the experimental group will be given an education and training booklet prepared in line with the literature by the researcher at the first interview. Only the training booklet will be given to the control group. Individuals in the experimental group will be called every 15 days for 3 months, in line with the Telephone Monitoring Instruction Form, to be interviewed and monitored. At the end of the 3rd month, the final tests will be applied. Individuals in the control group will be given post-tests at the end of the 3rd month..
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Other: Education and Telephone Follow-upthe group to be trained and then monitored by phone |
| CONTROL GROUP | No intervention | –The individuals in this group will be given only education booklet by the researcher after the pre-tests are applied in the first face-to-face interview. 3 months after the first interview, the final tests will be applied. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to participate in the research,
- Literate and open to communication,
- Knowing the diagnosis,
- Those aged 45 and over,
- Receiving short-term or long-term ADT treatment,
Key exclusion criteria (2 listed)
- Having a mental or psychiatric illness that prevents communication,
- Those with vision-hearing problems
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 |
|---|---|---|
| Education and Telephone Follow-upThe individuals in this group will be given an education and training booklet by the researcher after the pre-tests are applied in the first face-to-face interview. After the first meeting, the individual will be called every 15 days, 5 times in total for 3 months, and the training will be repeated in line with the individual's needs. After 3 months, the final tests will be applied. | Other | EXPERIMENTAL GROUP |
Primary outcome
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
Time frame: Through study completion, an average of 3 months
It is a questionnaire to measure quality of life which consists of three parts, namely "General Health Status Scale", "Functional Scale", "Symptom Scale" and a total of 30 questions. The last two questions (29,30); provides an assessment of the global quality of life. Each item in the scale is evaluated between 0 and 100 points. For each of the 28 questions in the functional scale and symptom scale, there are four options as none (1 point), a little (2 points), quite (3 points), a lot (4 points). On the general health scale, there are options ranging from very bad to excellent in the range of 1-7 points. Higher values represent a better situation
EORTC QLQ-PR25 Prostate Module
Time frame: Through study completion, an average of 3 months
It is a questionnaire to measure quality of life and consisting of 25 items. Prostate Cancer-specific side effects related to surgery, radiotherapy or hormonal therapy that are not in QLQ-C30; voiding problems, bowel functions, sexual status. It consists of two functional (sexual activity and sexual function) and four symptom scales (urinary, intestinal, hormone therapy-related symptoms and incontinence). The score of each item in the scale is evaluated by converting it into a linear range of 0 to 100 points. For each of the 25 questions in the module, there are four options: none (1 point), a little (2 points), quite (3 points), a lot (4 points). A high score from the functional scale indicates a high functional level, and a high score from the symptom scale indicates that the symptoms are experienced intensely.
8 secondary outcomes
The blood pressure measurements
Time frame: 3 months
The heart rate measurement
Time frame: 3 months
Weight
Time frame: 3 months
Height
Time frame: 3 months
BMI
Time frame: 3 months
Waist/Hip circumference measurement
Time frame: 3 months
Prostate Spesific Antigen (PSA)
Time frame: 3 months
Glucose 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 1 Mar 2023.
- Individual participant dataSharing planned: No
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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 Education and Telephone Follow-up in people with Prostate Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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 1 Mar 2023. 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 Turkey (Türkiye). 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?
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale (time frame: Through study completion, an average of 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 1 Mar 2023.