Telenursing and Breast Cancer: The Turkish Case

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Behavioral: Telenursing and Counseling

• Registration Number: NCT04480229
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary

This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey.

Detailed Description

This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey. The study employs an experimental research methodology with a sample of 96 ambulatory patients (48 experimental, 48 control) who were receiving chemotherapy for breast cancer for the first time in a state hospital. Research data were collected by using "Patient Information Form", "Edmonton Symptom Assessment Scale", "General Comfort Questionnaire, "Symptoms Follow-up Form", and "Telephone Call Form". The experimental group received telenursing service every week until the end of the four-cycle chemotherapy treatment, which started one week after the first treatment. The control group did not receive any intervention. Investigators analyzed data with SPSS 15.0 (Statistical Package for the Social Sciences) with comparative statistical methods of MannWhitney U Test, Chi-Square Test, One Way Analysis of Variance in Repeated Measurements, and Pearson Correlation.

Study Timeline

• Study Start: 2016-05-06
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-22
• Study First Submitted: 2020-06-03
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• is volunteering to participate in the research,
• is 18 years of age or over,
• can communicate in Turkish,
• has Turkish literacy skills,
• has no hearing, vision problems, and mental disability that may hinder communication,
• is female,
• has a diagnosis of breast cancer for the first time in her life and consequently receiving chemotherapy treatment in the same protocols for the first time,
• did not have a different diagnosis of cancer and related chemotherapy treatment.

Exclusion Criteria

• Having been diagnosed with breast cancer before and received chemotherapy treatment accordingly,
• Having been diagnosed with different cancers before and had chemotherapy treatment related to it,
• Cancer treatment with oral medications,
• Refuse to participate in the study
• Refuse education/counseling
• Not knowing Turkish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Telenursing and Counseling	After the first treatment, every week the patients were called and consulted by telenursing. During the next there chemotherapy treatments, Edmonton Symptom Assessment System and General Comfort Questionnaire were filled. The study ended with the fourth cycle chemotherapy. A total of six telephone calls and 3 face-to-face follow-ups were done with each of the intervention group patients. Face-to-face follow-up with patients during chemotherapy treatments lasted for about 20-30 minutes, and patients were evaluated three times in terms of symptom severity and comfort level.

Primary Outcome Measures

Name	Time	Method
Edmonton Symptom Assessment System	10 minutes	This tool is designed to assist in the assessment of symptoms common in cancer patients: pain,fatique, nausea, sadness, anxiety, insomnia, anorexia, wellbeing and shortness of breath, change in skin-nails, mucositis and numbness in hands. The patient circles the most appropriate number to indicate where the symptom is between "0" and "10". "0" is the minimum value, which means there is no change and it is a better outcome for the patient. "10" is the maximum value, means that the symptom level is the highest, which is a worse outcome for the patient.

Secondary Outcome Measures

Name	Time	Method
General Comfort Questionnaire	10 minutes	It is used to evaluate the situation of achieving the expected comfort increase result with nursing interventions that provide comfort. The scale, which is a four-point likert type, has a total of 48 items, 24 items are positive and 24 items are negative.; The lowest value that can be taken is 1 which indicates low comfort and this is a worse outcome. The highest value 4 indicates high comfort, which is a better outcome. The response patterns of the scale, which consists of positive and negative items, are given in mixed form. Accordingly, from positive statements; high score (4p) indicates high comfort, low score (1p) indicates low comfort, while negative items indicate low comfort (1p), high score (4p) low comfort.