CancerNCT04162717
The Effect of Telephone Symptom Triage Protocols in Patients With Cancer Therapy (TeleTRIAGE)
A study testing The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment in people with Cancer and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Self Efficacy
- What is being tested?
- The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 15 Sep 2019
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to come to Medical Oncology Polyclinic and Chemotherapy Unit for outpatient treatment
- First-time diagnosed cancer
- Know her/his diagnossis and/or able to express verbal
- Having undergone a cure chemotherapy treatment
- Chemotherapy was applied every 21-28 days
- Between 18-65 years (not to interfere with physical, psychological and functional problems that may develop due to old age)
Show all 11Show fewer
- Able to understand and write Turkish
- Able to use mobil telephone
- No disability to answer questions physically, cognitively or spiritually
- Non-bed dependent
- Willing to participate
Who cannot join
- Having diagnosed with psychiatric disease
- Having memory or cognitive disorder
- Patients receiving chemotherapy every seven or 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients With Cancer Who Applied Systemic Treatment: A Randomized Controlled Trial
The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained. The sample of the study included 70 cancer (35 interventions and 35 controls) patients who were treated with chemotherapy were randomized into the computer program.
According to the interference protocol of the study: Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests (Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale) were performed after obtaining consent. After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy. During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage. In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom. The patients in the control group did not undergo any intervention other than routine hospital follow-up. Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months.
Read the detailed description
The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study.
Before starting the research, permissions were taken. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained.
The sample of the study included cancer patients who were treated with chemotherapy in the Akdeniz University Hospital Day Chemotherapy Unit. The study included 80% power, 95% reliability and 0.05 error margins, and 70 patients (35 interventions and 35 controls) were randomized into the computer program.
According to the interference protocol of the study:
- Four patients who received systemic chemotherapy were tested with pilot study.
- Patients were included in the study according to the inclusion criteria and randomization list.
- Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests were performed after obtaining consent. For this purpose, Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale were applied.
- After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. Information about the contents of the guide was made between 10:00-14:00 hours during working hours during the week and it took an average of 15-20 minutes.
- The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy.
- During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage.
- In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom.
- In case of urgent necessity, patients were referred from the second consultant who were from Medical Oncology Department.
- The frequency of calls for the symptom triage protocol application of the intervention group was monitored and the information was recorded in the intervention group telephone interview form.
- The patients in the control group did not undergo any intervention other than routine hospital follow-up.
- Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months.
- Conditions
- Cancer, Self Efficacy
- Being tested
- The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment
- Keywords
- Patients with cancer, Symptom triage, Self care, Symptom management, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic TreatmentBehavioural
Symptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later.
Intervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Telephone Symptom Triage Protocols | Experimental | Intervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles.
Symptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later. Receives: Behavioral: The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment |
| Control group | No intervention | The control group received standard nursing care applied at the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Symptom Assessment Scale (C-SAS)
The scale was developed by Brown et al. (2001) in the UK and aims to measure 24 chemotherapy symptoms in cancer patients receiving chemotherapy. C-SAS consists of three parts.The highest and lowest scores are not calculated for the total score in the scale. Since each symptom is evaluated separately, the median values are calculated instead of the arithmetic mean. In this study, Turkish version of the scale was used.
Measured: 12 week
Functional Assessment of Cancer Therapy Forum-General - FACT-G (Version 4)
The scale was developed by "Center on Outcomes, Research, and Education Northwestern Healthcare" in USA and it is used to evaluate the quality of life of malignant patients.The FACT-G assesses four dimensions of quality of life: physical status, social and family status, emotional status and activity status.The FACT-G contains 27 items and each item score ranges from 0 to 5.The total score is between 0-108. High score indicates that the individual perceives life quality is to be high. In this study, Turkish version of the scale was used.
Measured: 12 week
The self-care agency scale
The scale was developed by Kearney ve Fleicher (1979) to measure people's ability to look after themselves or their power. The scale contains 35 items and each item score ranges from 0 to 5. The highest and lowest possible score is between 35-140. The scores according to the Self-Care Agency scale is considered 24-64 points are as poor, 65-100 points as moderate, 101-112 points as good and 113-138 points as very good self-care power level. The higher scores indicates better self-care ability of the individual. In this study, Turkish version of the scale was used.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 May 2018
- Primary completion31 Oct 2018
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arife ALTIN ÇETİN, Akdeniz University
- Investigators
- Hicran BEKTAŞ, Professor, Study chair, Akdeniz University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162717
- Sponsor's protocol ID
- 0010
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cetin AA, Bektas H, Coskun HS. The effect of telephone triage on symptom management in patients with cancer undergoing systemic chemotherapy: A randomized controlled trial. Eur J Oncol Nurs. 2022 Dec;61:102221. doi: 10.1016/j.ejon.2022.102221. Epub 2022 Oct 13.
PubMed 36332454
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients With Cancer Who Applied Systemic Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04162717
- Acronym / sponsor ID
- 0010
- Conditions
- Cancer, Self Efficacy
- Keywords
- Patients with cancer, Symptom triage, Self care, Symptom management, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 14 Nov 2019 (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.
The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained. The sample of the study included 70 cancer (35 interventions and 35 controls) patients who were treated with chemotherapy were randomized into the computer program.
According to the interference protocol of the study: Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests (Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale) were performed after obtaining consent. After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy. During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage. In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom. The patients in the control group did not undergo any intervention other than routine hospital follow-up. Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months.
Detailed description
The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study.
Before starting the research, permissions were taken. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained.
The sample of the study included cancer patients who were treated with chemotherapy in the Akdeniz University Hospital Day Chemotherapy Unit. The study included 80% power, 95% reliability and 0.05 error margins, and 70 patients (35 interventions and 35 controls) were randomized into the computer program.
According to the interference protocol of the study:
- Four patients who received systemic chemotherapy were tested with pilot study.
- Patients were included in the study according to the inclusion criteria and randomization list.
- Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests were performed after obtaining consent. For this purpose, Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale were applied.
- After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. Information about the contents of the guide was made between 10:00-14:00 hours during working hours during the week and it took an average of 15-20 minutes.
- The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy.
- During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage.
- In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom.
- In case of urgent necessity, patients were referred from the second consultant who were from Medical Oncology Department.
- The frequency of calls for the symptom triage protocol application of the intervention group was monitored and the information was recorded in the intervention group telephone interview form.
- The patients in the control group did not undergo any intervention other than routine hospital follow-up.
- Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Effect of Telephone Symptom Triage Protocols | Experimental | Behavioral: The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic TreatmentIntervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles. Symptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later. |
| Control group | No intervention | –The control group received standard nursing care applied at the hospital |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able to come to Medical Oncology Polyclinic and Chemotherapy Unit for outpatient treatment
- First-time diagnosed cancer
- Know her/his diagnossis and/or able to express verbal
- Having undergone a cure chemotherapy treatment
- Chemotherapy was applied every 21-28 days
Key exclusion criteria (3 listed)
- Having diagnosed with psychiatric disease
- Having memory or cognitive disorder
- Patients receiving chemotherapy every seven or 14 days
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 |
|---|---|---|
| The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic TreatmentSymptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later. Intervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles. | Behavioural | The Effect of Telephone Symptom Triage Protocols |
Primary outcome
Chemotherapy Symptom Assessment Scale (C-SAS)
Time frame: 12 week
The scale was developed by Brown et al. (2001) in the UK and aims to measure 24 chemotherapy symptoms in cancer patients receiving chemotherapy. C-SAS consists of three parts.The highest and lowest scores are not calculated for the total score in the scale. Since each symptom is evaluated separately, the median values are calculated instead of the arithmetic mean. In this study, Turkish version of the scale was used.
Functional Assessment of Cancer Therapy Forum-General - FACT-G (Version 4)
Time frame: 12 week
The scale was developed by "Center on Outcomes, Research, and Education Northwestern Healthcare" in USA and it is used to evaluate the quality of life of malignant patients.The FACT-G assesses four dimensions of quality of life: physical status, social and family status, emotional status and activity status.The FACT-G contains 27 items and each item score ranges from 0 to 5.The total score is between 0-108. High score indicates that the individual perceives life quality is to be high. In this study, Turkish version of the scale was used.
The self-care agency scale
Time frame: 12 week
The scale was developed by Kearney ve Fleicher (1979) to measure people's ability to look after themselves or their power. The scale contains 35 items and each item score ranges from 0 to 5. The highest and lowest possible score is between 35-140. The scores according to the Self-Care Agency scale is considered 24-64 points are as poor, 65-100 points as moderate, 101-112 points as good and 113-138 points as very good self-care power level. The higher scores indicates better self-care ability of the individual. In this study, Turkish version of the scale was used.
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 14 Nov 2019.
- Derived from this study: PubMed 36332454Cetin AA, Bektas H, Coskun HS. The effect of telephone triage on symptom management in patients with cancer undergoing systemic chemotherapy: A randomized controlled trial. Eur J Oncol Nurs. 2022 Dec;61:102221. doi: 10.1016/j.ejon.2022.102221. Epub 2022 Oct 13.
- 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.
Hicran BEKTAŞ, Professor study chair
Akdeniz University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment in people with Cancer and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 11 inclusion and 3 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Chemotherapy Symptom Assessment Scale (C-SAS) (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162717, which also lists 1 linked publication.
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 14 Nov 2019.