Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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11 June 2018 |
Main ID: |
ACTRN12618000500257 |
Date of registration:
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06/04/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Effect of Educational and Counseling Support on Stress, Adjustment and Health-Related Quality of Life in Women with Breast Cancer in Yemen
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Scientific title:
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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 |
Date of first enrolment:
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10/07/2017 |
Target sample size:
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120 |
Recruitment status: |
Active, not recruiting |
URL:
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http://www.anzctr.org.au/ACTRN12618000500257.aspx |
Study type:
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Interventional |
Study design:
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Non-randomised trial
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Phase:
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Quality of life in breast cancer patients
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Adjustment to breast cancer patients
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Stress in breast cancer patients at time diagnosis
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Intervention(s)
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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).
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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