Clinical trial NCT05683652: The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power
Official title: The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Care
Symptom Management
Immunotherapy
Cancer Patient
Keywords: Immunotherapy
Symptom Management
Self care power
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nightingale Symptom Rating Scale
timeFrame: In patients receiving immunotherapy, the first measurements will be made at the end of the 1st cycle (the cycle is 28 days)
measure: Demographic and Medical Characteristics - Patient Information Form
timeFrame: It will meet within 3 months with patients who agree to participate in the study.
measure: Telephone Interview Form
timeFrame: Patients in the experimental group receiving immunotherapy will be followed up by phone for 3 months.
measure: Phone Call Evaluation Form
timeFrame: It will be applied to the patients in the experimental group as a result of 3-month follow-up.
measure: Self Care Power Scale
timeFrame: The first measurements of the patients receiving immunotherapy will be done at the end of the 1st cycle (each cycle is 28 days)
Secondary outcomes:
measure: Nightingale Symptom Rating Scale
timeFrame: In patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
measure: Self Care Power Scale
timeFrame: n patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
Study officials:
References: