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Symptom Management, Education and Telephone Follow-up, Quality of Life,

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education and Telephone Follow-up
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen Deprivation Therapy, Telephone Follow-up, Nursing Education

Eligibility Criteria

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

Inclusion Criteria: 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, Exclusion Criteria: Having a mental or psychiatric illness that prevents communication, Those with vision-hearing problems

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EXPERIMENTAL GROUP

CONTROL GROUP

Arm Description

the group to be trained and then monitored by phone

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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".
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.
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".
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".
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.
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".
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".
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".

Full Information

First Posted
October 31, 2022
Last Updated
February 28, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof. Dr. Ayfer ÖZBAŞ
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1. Study Identification

Unique Protocol Identification Number
NCT05613881
Brief Title
Symptom Management, Education and Telephone Follow-up, Quality of Life,
Official Title
The Effect of Education and Telephone Follow-up on Quality of Life and Symptom Management in Patients Receiving Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof. Dr. Ayfer ÖZBAŞ

4. Oversight

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

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Androgen Deprivation Therapy, Telephone Follow-up, Nursing Education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The participant does not know which group he is in.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
the group to be trained and then monitored by phone
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education and Telephone Follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
Description
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
Time Frame
Through study completion, an average of 3 months
Title
EORTC QLQ-PR25 Prostate Module
Description
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.
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
The blood pressure measurements
Description
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".
Time Frame
3 months
Title
The heart rate measurement
Description
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.
Time Frame
3 months
Title
Weight
Description
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".
Time Frame
3 months
Title
Height
Description
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".
Time Frame
3 months
Title
BMI
Description
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.
Time Frame
3 months
Title
Waist/Hip circumference measurement
Description
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".
Time Frame
3 months
Title
Prostate Spesific Antigen (PSA)
Description
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".
Time Frame
3 months
Title
Glucose level
Description
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".
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, Exclusion Criteria: Having a mental or psychiatric illness that prevents communication, Those with vision-hearing problems
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Symptom Management, Education and Telephone Follow-up, Quality of Life,

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