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Trial Title:
The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power
NCT ID:
NCT05683652
Condition:
Self Care
Symptom Management
Immunotherapy
Cancer Patient
Conditions: Keywords:
Immunotherapy
Symptom Management
Self care power
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
TRAINING BOOKLET
Description:
Cancer patients in the intervention group, who will receive immunotherapy for the first
time, will be given face-to-face training with the prepared training booklet and followed
up by phone. Patients who received immunotherapy after the 1st, 2nd and 3rd cycles,
respectively, will be called by phone. The researcher's phone number will be given to the
intervention group patients and they will be told that they can call 24/7 if they
experience any symptoms. The telephone interview form created by the researcher will be
used during the monitoring by telephone.
Other name:
Telephone follow up
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.
Criteria for 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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ankara Medipol University
Address:
City:
Ankara
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Lecturer
Phone:
5077476389
Start date:
June 30, 2021
Completion date:
April 2023
Lead sponsor:
Agency:
Ankara Medipol University
Agency class:
Other
Source:
Ankara Medipol University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05683652
