The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power

This study, it was aimed to evaluate the effects of education and telephone follow-up given to cancer patients receiving immunotherapy on symptom management and self-care power. It is expected that the education given to the patients who will receive immunotherapy for the first time and the monitoring by phone, prevention of immunotherapy-related side effects, early recognition, and follow-up will reduce unnecessary hospital admissions and increase the self-care power of the patient.

Study Overview

• Status: Recruiting
• Conditions: Self Care; Immunotherapy; Symptom Management; Cancer Patient
• Intervention / Treatment: Device: TRAINING BOOKLET

Detailed Description

The research consists of two parts. For the qualitative part of the research; A semi-structured interview form was created. In this form, face-to-face interviews were conducted with the patients receiving immunotherapy about the symptoms they experienced, how they coped, and the subjects they wanted to learn.

Quantitative part for sample selection; G Power 3.1 statistical program was used to calculate the sample size of the study. After calculating the effect size as 0.73 by using the standard deviation and group averages of the Self-Care Scale of the study closest to the research, the sample calculation was made (Çetin,2020). According to this; The sample size was calculated with a total of 56 patients, 28 people in both groups, with a power of 85% in the 95% confidence interval. However, due to the possible losses in the number of patients, 33 people were planned for both groups, with a total of 66 patients (Çetin A.A.2020).

A randomization list created with a computer-based random number sequence was used to ensure the random distribution of the patients scheduled for immunotherapy to the groups (www.random.org). The patients were numbered according to the order of arrival, and the patients were assigned to the groups (intervention group with training and followed up by phone, and control group with routine follow-up) according to the numbers in the randomization list. Due to the nature of the study, the principal investigator and patients could not be blinded during grouping. However, single-blind randomization was achieved by blinding the evaluator groups.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara Medipol University
    • Contact: Lecturer; Phone Number: 5077476389

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability to read and write in Turkish,
• Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
• Not having any physical discomfort in the area of hearing or speaking that would prevent telephone conversations,
• Will receive immunotherapy for the first time and only,
• Willingness to participate in the research,
• Willingness to participate in the research,
• Patients who agreed to participate in the study verbally and in writing were included in the study.

Exclusion Criteria:

• Not being voluntarily or willing to participate in the research,
• Will receive radiotherapy or chemotherapy together with immunotherapy,
• Not knowing that he will receive immunotherapy,
• Patients who did not accept to participate in the study were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nightingale Symptom Rating Scale	Nightingale Symptom Assessment Scale (N-SDS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner in 2009 for cancer patients. Consisting of 38 items in total, the scale (N-CSS) has three sub-dimensions: Physical Well-Being (Physician) (items 1-4, 6-15, 23-27 and 37), Social Well-Being (SoIH) (5 and Articles 16-22) and Psychological Well-Being (PSYH) (Articles 28-36 and 38). When each item in the scale is used alone, it can be reflected how the cancer patients who are planned to receive or receiving chemotherapy are affected by the disease/treatment-related problems. In this Likert-type scale, the answer given by the patient to the evaluated item is scored as "0", if it is very little, "1", if it is a little, "2", if it is quite a lot, "3", and if it is too much, it is scored as "4". A high score indicates that the level of being affected by the disease/treatment-related problems is high.	In patients receiving immunotherapy, the first measurements will be made at the end of the 1st cycle (the cycle is 28 days)
Demographic and Medical Characteristics - Patient Information Form	It consists of a total of 8 questions created by the researcher after the literature review. 6 questions include medical characteristics, 2 questions include demographic characteristics.	It will meet within 3 months with patients who agree to participate in the study.
Telephone Interview Form	atients who were given pre-immunotherapy training will be called after each cure and interviewed for symptom management. A telephone interview form was created by the researcher to record the interviews.	Patients in the experimental group receiving immunotherapy will be followed up by phone for 3 months.
Phone Call Evaluation Form	A phone call evaluation form prepared by the researcher will be used to evaluate the phone calls made after each cure. It will be applied to the intervention group as a post-test.	It will be applied to the patients in the experimental group as a result of 3-month follow-up.
Self Care Power Scale	The scale used to measure an individual's self-care ability or self-care power was developed by Kearney and Fleicher (1979) in English with 43 items, and is a 35-item shortened Turkish form. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale. Among the answer options, "Doesn't describe me at all" is given 0 points, the others are given 1 point for "Doesn't describe me very well", 2 points for "I have no idea", 3 points for "Describes me a little", and 4 points for "Describes me a lot".In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no limit/cut off value.	The first measurements of the patients receiving immunotherapy will be done at the end of the 1st cycle (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nightingale Symptom Rating Scale	Nightingale Symptom Assessment Scale (N-SDS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner in 2009 for cancer patients. Consisting of 38 items in total, the scale (N-CSS) has three sub-dimensions: Physical Well-Being (Physician) (items 1-4, 6-15, 23-27 and 37), Social Well-Being (SoIH) (5 and Articles 16-22) and Psychological Well-Being (PSYH) (Articles 28-36 and 38). When each item in the scale is used alone, it can be reflected how the cancer patients who are planned to receive or receiving chemotherapy are affected by the disease/treatment-related problems. In this Likert-type scale, the answer given by the patient to the evaluated item is scored as "0", if it is very little, "1", if it is a little, "2", if it is quite a lot, "3", and if it is too much, it is scored as "4". A high score indicates that the level of being affected by the disease/treatment-related problems is high.	In patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Self Care Power Scale	The scale used to measure an individual's self-care ability or self-care power was developed by Kearney and Fleicher (1979) in English with 43 items, and is a 35-item shortened Turkish form. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale. Among the answer options, "Doesn't describe me at all" is given 0 points, the others are given 1 point for "Doesn't describe me very well", 2 points for "I have no idea", 3 points for "Describes me a little", and 4 points for "Describes me a lot".In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no limit/cut off value.	n patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)

Collaborators and Investigators

• Sponsor: Ankara Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Immunotherapy; Symptom Management; Self care power
• Other Study ID Numbers: E-84892257-300-100327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No