Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000095167
Ethics application status
Approved
Date submitted
18/12/2018
Date registered
22/01/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
22/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Psychological Education on Quality of Life among Jordanian Women Diagnosed with Breast Cancer
Scientific title
Effectiveness of Psycho-Education Intervention Program on Quality of Life and Coping Strategies and Psychological Distress among Jordanian Women Diagnosed with Breast Cancer
Secondary ID [1] 296887 0
Nil known
Universal Trial Number (UTN)
U1111-1225-6458
Trial acronym
Psycho-Education Intervention Trial (PEIT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor Quality of life (QOL) for breast cancer patients 310822 0
Psychological distress (anxiety,depression) for breast cancer patients 310823 0
Emotional-focus coping strategy rather than Problem-focus coping strategy among women with breast cancer 310824 0
Condition category
Condition code
Public Health 309496 309496 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psycho-Education Intervention Program (PEIP)
This intervention will be developed and implement among women who are diagnosed with non-metastatic breast cancer, consisting of two main components, medical education and sharing experiences. The medical education will be provided by clinical oncologist, and the sharing experience support will be offered by a breast cancer survivor. We choose the survivors of cancer to provide a support session because they have experienced cancer and overcome it. There will be a calming technique training session provided by voluntary psychiatric therapist.The intervention will be given in two days,the first day will have two sessions and the second day three sessions. Each session includes health message on breast cancer.The title for each session will be (Breast cancer fact, lifestyle/habit, problem-solving skill, interpersonal relationships, sharing experience). Each session will take approximately 2 hours in length delivered by face-to-face interactions, with total 10 hours over two days. The intervention will be prepared in English language, later translated into "Arabic" language. The clinical oncologist will provide the intervention by using open-ended questions to help the patient describe her problem and explain it as a story in her own words. The lectures will be presented in a slide power point presentation and show some videos related to disease. A booklet will be given to all participant in both group (control and intervention),which contains a five health messages.
The booklet will be designed as a supplement to the sessions, where it addresses five health messages. The messages were designed according to the breast cancer journey and will be given in parallel with the awareness sessions. In each session, the patient will be given a health message, which will be suitable with the session topic that will be attended.The health messages in the booklet are the same those presented in each psycho-educational session. The aims of booklet to find the best answer for the five questions that well be started in each session, and to reinforcement of knowledge that will be given in program.In order to assess the participants level of compliance and adherence, the will provide attendance log before and after each session of the intervention.


why:To enhance the reappraisal of stressful situation that reduce the psychological distress, and promote quality of life through enhancing coping strategies.
when: the intervention will start at (8 am till 2 pm) ,three times daily from (8 am -10 am),(10 am-12 md),and (12 md-2 pm).
How: It will be two days, each day we will interview a max 50 patients, 17 patients per group. 17* 3 =50 patients/day.
where:The location will be the Clinical Radiation Oncology Department (CROD),in Al-Bashir Hospital, which is a multi-specialty teaching hospital, located in the middle zone in the central city of Amman, Jordan.
Intervention code [1] 313162 0
Behaviour
Comparator / control treatment
The patients in control group will be receiving standard care intervention which offers multiple services to support the mental well-being of cancer patients through advice and spiritual support. And included different patients who were diagnosed with cancer in different stages. Also, the intervention not specific for breast cancer patients, however the intervention included calming technique in two sessions per weeks, Each session will take approximately 15-20 min and will be arranged by social welfare services team care. The clinical oncology doctor will refer the patients who need this intervention, the patients will take appointment to attend the intervention at rehabilitation center. Participants in this group will be randomly allocated in sequence and will be followed by the research team to fill out the questionnaire pre and post-intervention.
Control group
Active

Outcomes
Primary outcome [1] 308456 0
Beck level of quality of life score to be assess by European Quality of life Questionnaires EORTC QLQ-30,EORTC QLQ-BR23,
The questionnaires were translated into the most languages, including Arabic language, and have been used in Arabic countries; in Egypt, UAE, and Jordan. Globally, the questionnaires are revised, reliable and valid instruments (Awad et al., 2008; Montazeri, 2010; Ohaeri, 2009; Tan, 2014).
Timepoint [1] 308456 0
At baseline, 2 weeks post intervention commencement, and 12 weeks post intervention commencement
Primary outcome [2] 308457 0
Beck level coping strategy score, assessed using Brief COPE -28. Coping Strategies Questionnaire.
The questionnaire was translated into most languages, including Arabic language. And have been used in Arabic countries; in Tunisian, Jordan, Globally, the questionnaires are revised, reliable and valid instruments. (Carver, 1997; Fogel, 2004; Hamdan- Mansour, 2013; Heydecke, 2004; Meyer, 2001; Nawel and Elisabeth, 2015; Perczek 2000).
Timepoint [2] 308457 0
At baseline, 2 weeks post intervention commencement, and 12 weeks post intervention commencement
Primary outcome [3] 308458 0
Beck level psychological distress score (depression,anxiety) assessed using Hospital Anxiety and Depression Scale (HADS) 14 items psychological distress Questionnaire.
Timepoint [3] 308458 0
At baseline, 2 weeks post intervention commencement, and 12 weeks post intervention commencement
Secondary outcome [1] 354997 0
'Nil'
Timepoint [1] 354997 0
'Nil'

Eligibility
Key inclusion criteria
1) Jordanian citizen has started chemotherapy or radiotherapy treatment.
2) Age group of 20 to 65 years (Al-Sulaiman et al., 2018).
3) Women diagnosis as breast carcinoma according to ICD-10.
4) Women with histologically confirmed with stage (0, I, II or III) of breast cancer.
5) Post-operative period of 6 months to 1 year (Mahapatro and Parkar, 2005).
6) Living permanently in Amman city.
7) Able to read and communicate in Arabic and have telephone number.
Minimum age
20 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Women who unable to attend the program or complete the questionnaires due to time constraints.
2) Women with History of psychiatric disorders or chronic systemic diseases such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis (Huang and Shi, 2016; Setyowibowo, 2017),(based on the screening from medical files).
3) Women who participating in similar study.
4) Patient with severe depression and anxiety during baseline survey. (Scores as normal 0-7, mild 8-10, moderate 11-14, and severe 14-21).According to HADS.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be done using random allocation sequence by randomized block design (RBD) with computer-generated randomization in the block, to achieve the random allocation assignment for each patient into each group; control and intervention groups. Each intervention and control groups will be assigned A and B group. Each block contain four patients, so the main researcher makes six block using following sequences (AABB, ABAB, ABBA, BAAB, BABA, BBAA), the block generated by computer which is higher than six will be excluded. The implementation of randomization process (random allocation sequence, enrollments, assignment), will be applied by main researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be entered and analysed using the IBM-SPSS version 24. Data exploration and cleaning will be done using descriptive statistics to check for missing data and wrong data entry, cases with missing values will be excluded on a pairwise analysis basis.
All numerical variables (Age, family income, duration of symptoms, lump size,
quality of life scoring, coping strategy scoring, psychological distress scoring) will be presented as mean and standard deviation after checking the normality distribution of the data. If the data violates the assumption of normality, median and interquartile range will be reported. For categorical variables such as type of breast cancer, type treatment, type of surgery, etc. will be presented as frequencies and percentages (%).
At univariable levels – all differences between group means will be analysed using Independent t-test, for pre and post time paired t-test will be used. For non-normally distributed data Mann Whitney test and Wilcoxon signed rank test will be used respectively. Association between the categorical independent variables with the intervention group will be analysed using Chi-square analysis and Fisher exact test.
At multivariable level – To determine the effectiveness Psycho-education intervention on quality of life, coping strategy and psychological distress Repeated measures ANOVA will be used, all assumptions will be assessed using the Levene's test for equality of variance, Mauchly's test of sphericity, and normality of residual using the histogram plot.
Results will be presented as Mean differences and 95% confidence interval of the mean differences and their P-values. Significance level will be considered as less than 0.05.

The researcher will used specific statistical test for each objectives of the study.

Specific objective Type analysis
Objective 1 Descriptive Statistics
Objective 2, 3 and 4 Repeated measures ANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2019
Date of last participant enrolment
Anticipated
28/02/2019
Actual
4/09/2019
Date of last data collection
Anticipated
1/06/2019
Actual
4/09/2019
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 21129 0
Jordan
State/province [1] 21129 0
Amman

Funding & Sponsors
Funding source category [1] 301459 0
University
Name [1] 301459 0
Universiti Sains Malaysia
Country [1] 301459 0
Malaysia
Primary sponsor type
Individual
Name
Mr.Murad Younis
Address
Al Madina sport, St 14/ Abbas Bin Firnas, Amman/Jordan,
PO Box 132222, Amman 13132, Jordan
Country
Jordan
Secondary sponsor category [1] 301212 0
None
Name [1] 301212 0
Address [1] 301212 0
Country [1] 301212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302193 0
Jordanian Ministry of Health
Ethics committee address [1] 302193 0
Ethics committee country [1] 302193 0
Jordan
Date submitted for ethics approval [1] 302193 0
01/04/2018
Approval date [1] 302193 0
02/07/2018
Ethics approval number [1] 302193 0
M B/Ethics Committee 9694
Ethics committee name [2] 302207 0
Jawatanankuasa Etika Penyelidikan (JEPeM)
Ethics committee address [2] 302207 0
Ethics committee country [2] 302207 0
Malaysia
Date submitted for ethics approval [2] 302207 0
16/08/2018
Approval date [2] 302207 0
24/12/2018
Ethics approval number [2] 302207 0
USM/JEPeM/18080386

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

Contacts
Principal investigator
Name 89430 0
Mr Murad Abdulraheem Younis
Address 89430 0
Al Madina sport, St 14/ Abbas Bin Firnas, Amman/Jordan,
PO Box 132222, Amman 13132, Jordan
Country 89430 0
Jordan
Phone 89430 0
0966554790631
Fax 89430 0
Email 89430 0
[email protected]
Contact person for public queries
Name 89431 0
murad abdulraheem younis
Address 89431 0
Al Madina sport, St 14/ Abbas Bin Firnas, Amman/Jordan,
PO Box 132222, Amman 13132, Jordan
Country 89431 0
Jordan
Phone 89431 0
0966554790631
Fax 89431 0
Email 89431 0
[email protected]
Contact person for scientific queries
Name 89432 0
Norsa`adah Bachok
Address 89432 0
Unit of Biostatistics and Research Methodology, School of Medical Sciences, Health Campus,Universiti Sains Malaysia,16150 Kota Bharu,kelantan,Malaysia
Country 89432 0
Malaysia
Phone 89432 0
+601974697469520
Fax 89432 0
Email 89432 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
For Confidentiality issues and Participants consent.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
819Ethical approval    376593-(Uploaded-17-12-2018-20-28-08)-Study-related document.jpeg
820Ethical approval    376593-(Uploaded-24-12-2019-04-50-59)-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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of psycho-education intervention programme on coping strategies among jordanian women diagnosed with breast cancer: A randomised controlled trial.2021https://dx.doi.org/10.2147/BCTT.S299584
N.B. These documents automatically identified may not have been verified by the study sponsor.