Breast Cancer FemaleNCT04480229
Telenursing and Breast Cancer: The Turkish Case
A study testing Telenursing and Counseling in people with Breast Cancer Female, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Telenursing and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2016to 22 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case
This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Telenursing and Counseling
- Keywords
- telenursing, breast cancer, chemotherapy, symptom management
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telenursing and CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (1)
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start6 May 2016
- Primary completion20 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cicek Yagci, Ph.D., Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480229
- Sponsor's protocol ID
- 50687469-1280-2190-14
- Status last verified
- Jul 2020
- First submitted
- 3 Jun 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case
- ClinicalTrials.gov ID
- NCT04480229
- Acronym / sponsor ID
- 50687469-1280-2190-14
- Conditions
- Breast Cancer Female
- Keywords
- telenursing, breast cancer, chemotherapy, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 6 May 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Telenursing and CounselingAfter 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telenursing and CounselingAfter 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. | Behavioural | Intervention Group |
Primary outcome
Edmonton Symptom Assessment System
Time frame: 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.
1 secondary outcome
General Comfort Questionnaire
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cicek Yagci, Ph.D. principal investigator
Istinye University
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing and Counseling in people with Breast Cancer Female, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Symptom Assessment System (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.