Telenursing and Breast Cancer: The Turkish Case

NCT04480229 | Completed

• 1 other identifier: 50687469-1280-2190-14
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female

Keywords

telenursing; breast cancer; chemotherapy; symptom management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• General Comfort Questionnaire

  10 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Telenursing and Counseling

No Intervention: Control Group

NO INTERVENTION

During their first treatment the "Patient Identification Form" was filled and they were trained, which is the routine practice of the clinic. Patients were informed about the "Symptom follow-up form", asked to mark the symptoms and signs they experienced due to the disease and treatment in the form between the two chemotherapy treatments and to note when they experienced and how they resolved this symptom. When the patients came to the second treatment, the first follow-up of the patients was done. The investigator filled Edmonton Symptom Assessment System and General Comfort Questionnaire forms via face-to-face interviews. The "Symptom Follow-up Form" given to the patients in the previous chemotherapy treatment was collected and the same new form was given. They were requested to bring this form in their next treatment. The same protocol was followed during the third and fourth chemotherapy treatment

Interventions

Telenursing and Counseling BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Having been diagnosed with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Telenursing; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nursing; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cicek Yagci, Ph.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 21, 2020
• Study Start: May 6, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 22, 2017
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share