Clinical trial NCT05613881: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen Deprivation Therapy
Telephone Follow-up
Nursing Education
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Ayfer ÖZBAŞ
First posted: 2022-11-14
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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..
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
timeFrame: Through study completion, an average of 3 months
measure: EORTC QLQ-PR25 Prostate Module
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: The blood pressure measurements
timeFrame: 3 months
measure: The heart rate measurement
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: Height
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
measure: Waist/Hip circumference measurement
timeFrame: 3 months
measure: Prostate Spesific Antigen (PSA)
timeFrame: 3 months
measure: Glucose level
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: