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

NCT ID: NCT05683652

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-04-30

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.

Conditions

Self Care; Symptom Management; Immunotherapy; Cancer Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

TRAINING BOOKLET

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.

Intervention Type: DEVICE

Other Intervention Names

Telephone follow up

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Gamze ALINCAK

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Medipol University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Lecturer

Role: primary

5077476389

Other Identifiers

E-84892257-300-100327

Identifier Type: -

Identifier Source: org_study_id