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

NCT ID: NCT05613881

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The participant does not know which group he is in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EXPERIMENTAL GROUP

the group to be trained and then monitored by phone

Group Type EXPERIMENTAL

Education and Telephone Follow-up

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prof. Dr. Ayfer ÖZBAŞ

UNKNOWN

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tuğba Sınmaz

RESEARCH ASSISTANT MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-74555795-050.01.04-185078

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.