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

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?

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Education and Telephone Follow-up

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL GROUP; the group to be trained and then monitored by phone	Other: Education and Telephone Follow-up; 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.
No Intervention: CONTROL GROUP; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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.	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".	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".	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.	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".	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".	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".	3 months

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Prof. Dr. Ayfer ÖZBAŞ

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer; Androgen Deprivation Therapy; Nursing Education; Telephone Follow-up
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: E-74555795-050.01.04-185078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No