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Trial registered on ANZCTR


Registration number
ACTRN12618000500257
Ethics application status
Approved
Date submitted
19/12/2017
Date registered
6/04/2018
Date last updated
6/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Educational and Counseling Support on Stress, Adjustment and Health-Related Quality of Life in Women with Breast Cancer in Yemen
Scientific title
The Effect of Educational and Counseling Support on Stress, Adjustment and Health-Related Quality of Life in Women with Breast Cancer in Yemen: non-randomized clinical trial protocol
Secondary ID [1] 293638 0
Nil known
Universal Trial Number (UTN)
U1111-1206-7468
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adjustment to breast cancer patients 305912 0
Stress in breast cancer patients at time diagnosis 305913 0
Quality of life in breast cancer patients 305914 0
Condition category
Condition code
Cancer 305105 305105 0 0
Breast
Mental Health 305106 305106 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Coping Intervention Module:
Based on the transaction Module of stress and coping theory, the stress arises as a result of an imbalance between demands and resources, and the patient become stressful when demands (pressure) exceeds her resources (her ability) (Lazarus & Folkman, 1984). The patient appreciates the stress events, and according to her ability have to use internal resources and external support to cope with stressful events (Friedman. S, 2002). Providing an education and counselling regarding her illness, can improve the sense of control and her resources (Lyons & Chamberlain, 2006), which, leads to improve her health statue, and quality of life (Coon & Mitterer, 2014). Moreover, the patient at the time of diagnosis, expresses greatest need to speak with woman who has experienced the same disease and already exceeded the crisis and now is leading an ordinary Life (Giese-Davis et al., 2006). The main objective for the intervention is to help woman to adapt with the breast cancer especially with women who are newly diagnosed.

Content of the Coping Intervention Module:
The intervention in this study will focused on providing education, information, and awareness related to the breast cancer, as well, offering concrete support and counselling. One session will be held weekly. The educational sessions will be held in the first three-consecutive weeks, then counselling sessions will be held in the following 4 consecutive weeks at the hospital during chemotherapy sessions. The total intervention sessions will be 7 sessions (total of 7 weeks): 3 sessions for the health education topics (3 weeks) and 4 sessions for the counselling support topics (4 weeks) + The booklet) will be provided across the sessions.

The Health Education:
The first axis of intervention is given information by an oncology physician, it consists of 3 sessions, 1 hour for each session weekly in three consecutive weeks, individual one-on-one at the oncology center. The education axis contains related information about cancer, its treatment, adverse effects of treatment, suitable nutrition and important of the physical activity for the breast cancer patients.

Counselling support:
The second axis is the counselling support, this axis will be performed by a psychologist and a breast cancer survivor. It will carry out in 4 sessions, 1 hour for each session weekly in consecutive weeks, individual one-on-one at the oncology center. It includes problem solving, interpersonal relationships, and emotional and social support. As well, the fourth session will be with the breast cancer survivor, she will discuss her experience and journey with breast cancer.

The Booklet:
The booklet was designed as a supplement to the sessions, where it addresses seven health messages with Arabic language. 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 illness phase. These messages include two printed educational messages about the suitable food for the cancer patient, and importance of the physical activity in improve the health status. In addition, five printed educational messages will be given to the patient include "the will is the secret-of-life us, be contented with what God ordains, cancer is not a death sentence, letter to my dear husband, and the new life". This axis will be performed by a breast cancer survivor, because the women at the diagnosis time need to speak with someone who has experienced the same disease and already exceeded this crisis and now is leading an ordinary Life (Giese-Davis et al., 2006).
Intervention code [1] 299898 0
Other interventions
Comparator / control treatment
Control group:
Patients in control group will receive the usual care. In the usual care, the oncologists usually provide an information about the disease and treatment side effects for the patient and her relatives. This information usually is not enough and depend on the doctor's free time. After receiving the last follow-up test (6 months after intervention), group education and counselling sessions will be implemented for the control group, as well, they will be given the booklet.
Control group
Active

Outcomes
Primary outcome [1] 304274 0
The primary outcome is the stress variable measures by using Perceived Stress Scale (PSS).
Timepoint [1] 304274 0
The stress will be assessed in the following timepoint:
Baseline survey (T1) /Pre-intervention (one day before intervention)
Mid-term survey (T2): Two Months after T1:
End-line Survey (T3): Post intervention / 6 months after T1:
Secondary outcome [1] 341459 0
Secondary outcome 1: Adjustment to breast cancer using Mini-Mental Adjustment to Cancer (Mini-MAC) scale
Timepoint [1] 341459 0
The Adjustment to breast cancer will be assessed in the following time-point:
Mid-term survey (T2): Two Months after T1:
End-line Survey (T3): Post intervention / 6 months after T1:
Secondary outcome [2] 341460 0
Secondary outcome 2: Quality of life using The European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR 23 Questionnaires.
Timepoint [2] 341460 0
The Quality of life will be assessed in the following time-point:
Baseline survey (T1) /Pre-intervention (one day before intervention)
Mid-term survey (T2): Two Months after T1:
End-line Survey (T3): Post intervention / 6 months after T1:

Eligibility
Key inclusion criteria
1. Yemeni citizens. 2. Be diagnosed with breast cancer for the first time. 3. Women who are 18 years or older. 4. Women Diagnosed with Stage I, II or III Breast cancer. 5. Women who undergo chemotherapy for breast cancer after surgery. 6. Score of 13 or less on the Perceived Stress Scale (PSS) 10 scale, would be considered low stress (Sheldon Cohen, 1988; S Cohen et al., 1983).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: 1. Pregnant woman. 2. Patient has any obstacles to communication. 3. Patients who are planning to receive the treatments out of the targeted cancer facilities. 4. A history of schizophrenia or schizo-affective disorder (Huang & Shi, 2016), use of antipsychotics, anxiolytics, or antidepressants or use of a stress management technique.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed by using the IBM- SPSS statistics version 22, for the uni-variate analysis, determining the significant predictors, and test the effectiveness of the intervention over time. Also, IBM.AMOS software will be used for analyzing the relationships; assessment of the mediating effect of the intervention, regression and data panel modeling. The statistically significant results will be tested by calculating p-value at alpha value 0.05 (P = 0.05), or by using confidence intervals (I.C). The data will be tested for meets the assumptions, which must be met if the test can be used. The questionnaires will be scored according to their scoring manuals; EORTC QLQ-C30 and QLQ-BR 23, PSS scale and Mini-Mac scale.
First of all, the data will be screened and reviewed (data entry, case screening, and variables screening), as well, missing date will be treated or replaced. The data will be organized, summarized, and presented in a convenient and informative way (the frequency distribution, draw the table and graphs). The frequency and percent will be used to describe the qualitative data and the MCT and MD will be used to describe the quantitative data for the participants' characteristics, clinical characteristics and dependent variables. The significance differences will be tested for the participants' characteristics and clinical characteristics to prove the similarities between them in the intervention and control group.
Secondly, the repeated measurement ANOVA will be used to assess the effectiveness of the intervention modal over time. The main effects and interaction effect between trails and intervention will be estimated too. If the assumption not meet, Friedman's test will be used. In case the result is significant, Wilcoxon Signed Rank test will be applied as a post-hoc test.
Thirdly, the multiple regression will be used to determine the relevant candidate predictor variables to the stress, adjustment and quality of life among women with breast cancer in Yemen. Then, the predictive model for this study will be developed after determining the significant predictor variables. Thereafter, the Panel analysis will be used to determine the effect of the relevant candidate predictor variables in the changes in the stress, adjustment and HRQOL over time. The Cross-Lagged Panel analysis will be used to determine the effect of the relevant candidate predictor variables in the changes of the stress, adjustment and HRQOL over time. Las but not least, Multi-Model Analysis (MMA) will be used to clarify the nature of the relationship between the stress and quality of life.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/07/2017
Date of last participant enrolment
Anticipated
Actual
10/11/2017
Date of last data collection
Anticipated
20/06/2018
Actual
Sample size
Target
120
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 9448 0
Yemen
State/province [1] 9448 0
Sana'a
Country [2] 9449 0
Yemen
State/province [2] 9449 0
Aden

Funding & Sponsors
Funding source category [1] 298256 0
Government body
Name [1] 298256 0
Ministry of Public Health & Population - Yemen
Country [1] 298256 0
Yemen
Primary sponsor type
Individual
Name
Prof. Dr: Muhamad Hanafiah Juni
Address
Department of Community Health
Faculty of Medicine & Health Sciences, Universiti Putra Malaysia
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 297811 0
Individual
Name [1] 297811 0
Dr. Hayati Kadir
Address [1] 297811 0
Department of Community Health
Faculty of Medicine & Health Sciences, Universiti Putra Malaysia
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country [1] 297811 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299259 0
Ethics committee for research involving human subjects, University of UPM, JKEUPM
Ethics committee address [1] 299259 0
Research Management Centre (RMC) Building Office of the Deputy Vice Chancellor (Research & Innovation) Floor 4 & 5 Universiti Putra Malaysia 43400 UPM Serdang, Selangor
Ethics committee country [1] 299259 0
Malaysia
Date submitted for ethics approval [1] 299259 0
19/06/2016
Approval date [1] 299259 0
07/07/2017
Ethics approval number [1] 299259 0
FPSK(EXP16)P161
Ethics committee name [2] 299260 0
National Health and Medical Research Committee (NHRMC), Yemen
Ethics committee address [2] 299260 0
Ministry of Health street, Ath'thaorah District, Amanat Al-Asimah, Sana'a
Ethics committee country [2] 299260 0
Yemen
Date submitted for ethics approval [2] 299260 0
11/05/2016
Approval date [2] 299260 0
30/07/2016
Ethics approval number [2] 299260 0
G7/85

Summary
Brief summary
The diagnosis of cancer is one of the most distressing and devastating events that may befall woman. It is considered a major stressful event that threats all aspects of woman's life, and can regarded as a challenge to woman’s basic values, beliefs and goals, life functions and threatening their sense of identity. At the time of diagnosis, the patient faces unmet information needs and express the greatest need to speak with someone who has experienced the same disease and already exceeded this crisis. In this study, related information and counselling will be provided to the breast cancer patient with aim to reduce the stress, and promote adjustment and quality of life.
Methods: A quasi-experimental with a comparison group will be used. The participants will be 120 breast cancer patients from a separate locations; the intervention group from the National Oncology Center in Sana’a and the control group will be chosen from the National Oncology Center in Aden and Cancer Center in Hadramout. The participants include all women in aged more than 18 years and have newly diagnosed with primary breast cancer (stage I, II and III). The intervention consists of seven sessions that include providing medical information and counselling support and a booklet contains seven messages.
The outcomes will be measured at baseline, 2 months and 6 months after baseline test., by using the Perceived Stress Scale to assess the stress degree, Mini-MAC scale to assess mental adjustment to cancer, and EORTC QLQ-C30 and QLQ-BR23 questionnaires to assess the quality of life. The magnitude of the dependent and independent variables will be determined, and repeated measurement will be used to assess the effectiveness of intervention over time. Additionally, the Significant predictive will be determined and mediating effect and the effect of of covariate in the changes in outcomes over time will be assessed.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2283 2283 0 0
/AnzctrAttachments/374191-The Effect of Educational and Counseling Support on Stress, Adjustment and Health-Related Quality of Life in Women with Breast Cancer in Yemen.pdf (Protocol)

Contacts
Principal investigator
Name 79822 0
Mr Ahmed Ali Ahmed Abdo
Address 79822 0
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 79822 0
Malaysia
Phone 79822 0
+967777255405
Fax 79822 0
+603-8945 0151
Email 79822 0
[email protected]
Contact person for public queries
Name 79823 0
Ahmed Ali Ahmed Abdo
Address 79823 0
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 79823 0
Malaysia
Phone 79823 0
+967777255405
Fax 79823 0
+603-8945 0151
Email 79823 0
[email protected]
Contact person for scientific queries
Name 79824 0
Muhamad Hanafiah Juni
Address 79824 0
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 79824 0
Malaysia
Phone 79824 0
+603-8947 2519/2424/2425
Fax 79824 0
+603-8945 0151
Email 79824 0
[email protected]

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