Clinical trial NCT04162717: The Effect of Telephone Symptom Triage Protocols in Patients With Cancer Therapy (TeleTRIAGE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Self Efficacy
Keywords: Patients with cancer
Symptom triage
Self care
Symptom management
Quality of life
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Able to come to Medical Oncology Polyclinic and Chemotherapy Unit for outpatient treatment
2. First-time diagnosed cancer
3. Know her/his diagnossis and/or able to express verbal
4. Having undergone a cure chemotherapy treatment
5. Chemotherapy was applied every 21-28 days
6. Between 18-65 years (not to interfere with physical, psychological and functional problems that may develop due to old age)
7. Able to understand and write Turkish
8. Able to use mobil telephone
9. No disability to answer questions physically, cognitively or spiritually
10. Non-bed dependent
11. Willing to participate

Exclusion Criteria:

1. Having diagnosed with psychiatric disease
2. Having memory or cognitive disorder
3. Patients receiving chemotherapy every seven or 14 days

Primary outcomes:
measure: Chemotherapy Symptom Assessment Scale (C-SAS)
timeFrame: 12 week
measure: Functional Assessment of Cancer Therapy Forum-General - FACT-G (Version 4)
timeFrame: 12 week
measure: The self-care agency scale
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Arife Altin Cetin
Study officials:
affiliation: Akdeniz University Faculty of Nursing
name: Hicran BEKTAŞ, Professor
role: STUDY_CHAIR
References:
citation: 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.