- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162717
The Effect of Telephone Symptom Triage Protocols in Patients With Cancer Therapy (TeleTRIAGE)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey, 07058
- Arife Altin Cetin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- Having diagnosed with psychiatric disease
- Having memory or cognitive disorder
- Patients receiving chemotherapy every seven or 14 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The Effect of Telephone Symptom Triage Protocols
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. |
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. |
No Intervention: Control group
The control group received standard nursing care applied at the hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 week
|
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.
|
12 week
|
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.
|
12 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hicran BEKTAŞ, Professor, Akdeniz University Faculty of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on 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
-
Akdeniz UniversityCompletedStroke, Ischemic | Self EfficacyTurkey