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

NCT05613881 | Completed

• 1 other identifier: E-74555795-050.01.04-185078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen Deprivation Therapy; Telephone Follow-up; Nursing Education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The blood pressure measurements

  3 months

• The heart rate measurement

  3 months

• Weight

  3 months

• Height

  3 months

• BMI

  3 months

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

the group to be trained and then monitored by phone

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.

Interventions

Education and Telephone Follow-up 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.

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Having a mental or psychiatric illness that prevents communication,
• Those with vision-hearing problems

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Prof. Dr. Ayfer ÖZBAŞ: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant does not know which group he is in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH ASSISTANT MSc

Model Details: 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..

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: May 15, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)