The Effect of Education and Telephone Follow-up on Quality of Life and Symptom Management in Patients Receiving Androgen Deprivation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- EORTC QLQ-PR25 Prostate Module
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Tuğba Sınmaz
RESEARCH ASSISTANT MSc
Istanbul University - Cerrahpasa (IUC)
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
Outcomes
Primary Outcomes
EORTC QLQ-PR25 Prostate Module
Time Frame: Through study completion, an average of 3 months
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.
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
Time Frame: Through study completion, an average of 3 months
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
Secondary Outcomes
- Weight(3 months)
- Prostate Spesific Antigen (PSA)(3 months)
- The heart rate measurement(3 months)
- The blood pressure measurements(3 months)
- BMI(3 months)
- Glucose level(3 months)
- Height(3 months)
- Waist/Hip circumference measurement(3 months)