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Telenursing and Breast Cancer: The Turkish Case

Primary Purpose

Breast Cancer Female

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telenursing and Counseling
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring telenursing, breast cancer, chemotherapy, symptom management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    No Intervention: Control Group

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 3, 2020
    Last Updated
    July 16, 2020
    Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04480229
    Brief Title
    Telenursing and Breast Cancer: The Turkish Case
    Official Title
    A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 6, 2016 (Actual)
    Primary Completion Date
    June 20, 2017 (Actual)
    Study Completion Date
    June 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Female
    Keywords
    telenursing, breast cancer, chemotherapy, symptom management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No Intervention: Control Group
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telenursing and Counseling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Edmonton Symptom Assessment System
    Description
    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.
    Time Frame
    10 minutes
    Secondary Outcome Measure Information:
    Title
    General Comfort Questionnaire
    Description
    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.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Having been diagnosed with breast cancer
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cicek Yagci, Ph.D.
    Organizational Affiliation
    Istinye University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Telenursing and Breast Cancer: The Turkish Case

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