The Effect of Telephone Symptom Triage Protocols in Patients With Cancer Therapy (TeleTRIAGE)

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162717
• Other study ID #: 0010
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: November 2019
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 15, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Self Efficacy

Intervention

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
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.

Locations

Country	Name	City	State
Turkey	Arife Altin Cetin	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 week
Primary	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.	12 week
Primary	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.	12 week