Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001220752
Ethics application status
Approved
Date submitted
13/08/2022
Date registered
9/09/2022
Date last updated
5/11/2023
Date data sharing statement initially provided
9/09/2022
Date results provided
9/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the effect of tele-nursing training and follow-up on self-efficacy and drug adherence on elderly cancer patients using oral anti-cancer drug
Scientific title
Investigation of the effect of tele-nursing training and follow-up on self-efficacy and drug adherence on elderly cancer patients using oral anti-cancer drug
Secondary ID [1] 307771 0
Nil known
Universal Trial Number (UTN)
U1111-1281-5904
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly cancer patients 327505 0
Drug Adherence 327506 0
Self-Efficacy 327507 0
Condition category
Condition code
Cancer 324473 324473 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The application of the research will be in the outpatient clinic of Gülhane Health Sciences University Medical Oncology Department. The research period is 12 weeks in total. The intervention will be performed by a specialist nurse with 9 years of experience.
First Meeting with Patients (Face to Face)
• Medication Adherence/Compliance Self-Efficacy Scale (MASES), Oral Chemotherapy Adherence Scale pre-test (first measurement) will be applied to the patients.
• The first training with the patients will be in the form of face-to-face training. This training will be done by the researcher. Conduct of the first training session: verbal instruction.Due diligence will be made about what information patients need to improve adherence to oral anticancer drug and the causes of treatment adherence problems.This training will be given to the patients in line with the Education Manual for Patients Using Oral Anticancer Drugs prepared by the researcher. The overall duration of the meeting 45-60 minutes.
• The patient's questions will be answered and it will be announced that the training will be started by telephone in order to reinforce the information given next week.
Education with Tele-nursing (1st Week, 2nd Week, 3rd Week, 4th Week)
• Patients will receive an educational video on their phone once a week for four weeks from the start of the study (The duration of the educational videos:1st video 1 minute 32 seconds, 2nd video 1 minute 35 seconds, 3rd video 3 minutes 27 seconds, 4th video 1 minute 48 seconds).
• In the same week, 4 text messages will be sent to the patient about the training video. Length of text messages: Each message consists of 1-3 sentences. It takes an average of 20-30 second to read each message.There will be important points in the education booklet in the messages sent to the participants.Educational videos provided have been designed specifically for this study.
•Of the four text messages to be sent each week, the 1st message will be sent on Monday, the 2nd message on Tuesday, the 3rd message on Wednesday and the fourth message on Thursday. The education video will be sent on Friday. Message ve education video it will be sent at 9 o'clock in the morning.
• Messages and education videos will be sent from the WhatsApp application to monitor compliance with the intervention in patients. Messages and videos sent in this way will be evaluated according to the blue tick status.
Follow-up with Tele-nursing (Week 5 - Week 12)
• It will start in the 5th week after the completion of the trainings given over the phone and continue until the 12th week.From week 5 to week 12, a phone call will be made every week.
• The content of tele-nursing will be shaped according to the patient. It will consist of questions that the patient does not understand in the messages and training videos, or the questions that the patient wants to ask about drug adherence. In addition, the researcher will focus on the issues that the patient has problems with in the use of oral anticancer drugs and suggestions will be made on these issues (for example: pain, nausea).The average duration of a weekly phone call is 5-15 minutes.
•Intermediate measurement (second measurement) Drug Treatment Adherence/Compliance Self-Efficacy Scale (MASES), Oral Chemotherapy Compliance Scale will be administered to the patients at the 8th week by the researcher. At the end of the telephone follow-up (at the 12th week), the study will be concluded by applying the Drug Treatment Adherence/Compliance Self-Efficacy Scale (MASES), Oral Chemotherapy Compliance Scale and Tele-nursing evaluation form as a post-test (third measurement) to the patients.
Intervention code [1] 324233 0
Behaviour
Comparator / control treatment
At the first meeting with the patients, the Medication Adherence/Compliance Self-Efficacy Scale (MASES), Oral Chemotherapy Adherence Scale pre-test (first measurement) will be applied face-to-face.
• Patients will be given an average of 30-45 minutes of training in line with the Education Manual for Patients Using Oral Anticancer Drugs.
• Medication Adherence/Compliance Self-Efficacy Scale (MASES), Oral Chemotherapy Adherence Scale will be administered to the patients as an interim measure (second measure) at week 8 and as a final test (third measure) at week 12.
• No intervention will be applied to the patients in the control group during the follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 332294 0
Drug adherence assessed using the Oral Chemotherapy Adherence Scale
Timepoint [1] 332294 0
Baseline, 8 and 12 weeks after the start of the intervention
Primary outcome [2] 332437 0
Self-efficacy assessed using the Medication Adherence/Compliance Self-Efficacy Scale (MASES)
Timepoint [2] 332437 0
Baseline, 8 and 12 weeks after the start of the intervention
Secondary outcome [1] 412867 0
Tele-nursing evaluation form.
This questionnaire has been designed for this study.
Timepoint [1] 412867 0
12 weeks after the start of the intervention

Eligibility
Key inclusion criteria
65 years and older,
• Being diagnosed with cancer and knowing its diagnosis,
• Having used at least one course of oral anticancer drugs,
• Using any of the oral anticancer drugs (in addition to oral chemotherapy, patients who receive additional IV chemotherapy and/or radiotherapy treatment will also be included),
• Having a telephone subscription and own telephone,
• Able to communicate verbally and in writing over the phone,
• Patients who agreed to participate in the study
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those who will not be able to communicate by phone,
• Having poor general condition,
• Having hearing, vision problems and cognitive problems that may prevent verbal and written communication,
• Mini-Mental State Test total score below 24,

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The results of a similar study by Sender Çakmak and Kapucu (2021) were used to determine the sample size. In this study, it is seen that the intervention was applied to the experimental and control groups, and the scale scores were evaluated before and after the application. In this study, the post-intervention MASES scores of the experimental and control groups; experiment; 57.9±9.59 and control; 48.0±9.23 (From Çakmak and Kapucu, 2021). By using the results obtained, power analysis was performed with the GPower3.1 package program and the sample size was calculated. According to the MASES scale score from these results; It was calculated that the sample should be at least 50 people (experimental 25, control 25) with 0.95 power, large effect size (1.05) and 0.05 alpha margin of error. It was increased by 20 and it was decided that the total sample size would be 60 people (30 people in the experimental group, 30 people in the control group).
In data analysis; When the parametric test prerequisites are met, it is envisaged to use the Factorial Variance Analysis method and then the Bonferroni test as a multiple comparison method if deemed necessary. Other methods that are foreseen to be used when parametric test prerequisites are met are Dependent two-group t-test (Paired t-test) and Independent two-group t-test (Student's t-test). If the prerequisites are not met, Friedman test, Wilcoxon test and Mann Whitney-U test will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/05/2022
Date of last participant enrolment
Anticipated
Actual
7/07/2022
Date of last data collection
Anticipated
20/10/2022
Actual
31/10/2022
Sample size
Target
60
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 24952 0
Turkey
State/province [1] 24952 0
Ankara

Funding & Sponsors
Funding source category [1] 312043 0
Self funded/Unfunded
Name [1] 312043 0
Country [1] 312043 0
Primary sponsor type
Individual
Name
Sümeyye Basoglu
Address
Gazi Üniversitesi Rektörlügü 06560 Emniyet Mahallesi Bandirma Caddesi No:6/1 Yenimahalle - ANKARA/ TURKEY
Country
Turkey
Secondary sponsor category [1] 313548 0
None
Name [1] 313548 0
Address [1] 313548 0
Country [1] 313548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311457 0
GAZI UNIVERSITY Ethics Commission
Ethics committee address [1] 311457 0
Ethics committee country [1] 311457 0
Turkey
Date submitted for ethics approval [1] 311457 0
Approval date [1] 311457 0
29/12/2021
Ethics approval number [1] 311457 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121162 0
Mrs Sümeyye Basoglu
Address 121162 0
Gazi Üniversitesi Rektörlügü 06560 Emniyet Mahallesi Bandirma Caddesi No:6/1 Yenimahalle - ANKARA/ TURKEY
Country 121162 0
Turkey
Phone 121162 0
+905545007885
Fax 121162 0
Email 121162 0
[email protected]
Contact person for public queries
Name 121163 0
Sümeyye Basoglu
Address 121163 0
Gazi Üniversitesi Rektörlügü 06560 Emniyet Mahallesi Bandirma Caddesi No:6/1 Yenimahalle - ANKARA/ TURKEY
Country 121163 0
Turkey
Phone 121163 0
+905545007885
Fax 121163 0
Email 121163 0
[email protected]
Contact person for scientific queries
Name 121164 0
Sümeyye Basoglu
Address 121164 0
Gazi Üniversitesi Rektörlügü 06560 Emniyet Mahallesi Bandirma Caddesi No:6/1 Yenimahalle - ANKARA/ TURKEY
Country 121164 0
Turkey
Phone 121164 0
+905545007885
Fax 121164 0
Email 121164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16909Ethical approval    384526-(Uploaded-13-08-2022-08-41-24)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.