Telenursing and Breast Cancer: The Turkish Case

Breast Cancer Female Clinical Trial

Official title:

A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480229
• Other study ID #: 50687469-1280-2190-14
• Status: Completed
• Phase: N/A
• Start date: May 6, 2016
• Est. completion date: June 22, 2017

Study information

• Verified date: July 2020
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 22, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Behavioral:
• Telenursing and Counseling
After the first face-to-face training, counseling on the phone was conducted every week for four cycles of chemotherapy treatment. In total, six counseling sessions and four face-to-face training sessions were conducted for each patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edmonton Symptom Assessment System	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.	10 minutes
Secondary	General Comfort Questionnaire	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.	10 minutes