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临床试验/NCT04843358
NCT04843358尚未招募不适用

Efficacy of Expressive Writing on Quality of Life Among Breast Cancer Survivors in Oman: A Double Blind Randomized Controlled Trial - A Study Protocol

Sultan Qaboos University0 个研究点目标入组 64 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
The difference in the mean scores of Functional Assessment of Cancer Therapy general scale: FACT-G V4

研究概览

简要总结

Background Breast cancer is the most common cancer affecting women globally. Additionally, it is the most common cause of cancer mortality among women. Internationally, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3% and affect more than 356,225 women. Psychologically, it has been shown that emotional suppression experienced by some women with breast cancer is highly predictive of low quality of life and psycho-somatic morbidities during the process of treatment. Such attitude towards emotional suppression is thriving well in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing proclivity. Expressive writing may provide a tool to meet such need. Taken together and given the lack of any study exploring EW effect of Quality of life in women with breast cancer. The current study aims to examine the impact of expressive writing on quality of life in a randomized controlled trial among cancer survivor in Oman.

Hypothesis The primary hypothesis states that compared to writing about neutral topic, expressive writing intervention will lead to a better improvement in quality of life among breast cancer patients after two months of the intervention.

Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention.

Method This study is a multicenter, prospective, double blind, parallel RCT with a 2-month follow-up and will be carried out at Oman's comprehensive cancer care & research center and Sultan Qaboos University Hospital, Muscat, Oman. Sixty four participants will be randomized to 3 sessions EWI group or neutral topic writing group, using a fixed randomization schedule allocating participant between the two intervention arms in a 1:1 ratio.

详细描述

Background Breast cancer is the most common cancer affecting women globally. Additionally, it is the most common cause of cancer mortality among women. Internationally, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3% and affect more than 356,225 women.

In the Middle eastern countries, breast cancer is responsible for the highest prevalence rate (21.9%), new incident (17.7%), and mortality (11.6%) caused by different types of neoplasms. In Oman, the incidence rate of breast cancer nearly doubled between 1996 and 2015 from 13.6 to 26.9 per 100 000 women. According to recent data from Ministry of Health, breast cancer is most of common cancer as it accounts for 24.4 percent of all registered cancer incidents in the Sultanate. Such data herald several repercussion at individual and societal levels from health as well as financial dimensions. Health related Quality of life of breast cancer patient is one main concern to be addressed in this context. Health-related quality of life refers to the extent to which one's usual or expected physical, emotional, and social functioning are touched by the cancer or its treatment. The time of diagnosis, initial stages of investigations, the treatment course, and the months following the end of treatment are challenging times for patients both physically and emotionally. During these times, uncertainties, difficulty to adjust and hampered quality of life are inevitable. Women diagnosed with breast cancer are no exception and could endure several emotional and physical challenges. Plethora of literature indicate that the survivorship time, after the surgery undergoing chemotherapy and radiotherapy, is often comes with psychological problems and reduced quality of life (QOL). The reasons for low quality of life among breast cancer population can be conceived of as bio-psycho-social. From biological aspect, chemotherapy side effects play a major a role. These include increased mental and physical symptoms such as anxiety, nausea, constipation, and anemia. Consequently, these side effects can have negative impact of on treatment of breast cancer. Perceived lack of social support, stigma of breast cancer diagnosis, and poor self-image have been recognized as significant moderators of quality of life among breast cancer women.

Psychologically, it has been shown that emotional suppression experienced by some women with breast cancer is highly predictive of low quality of life and psycho-somatic morbidities during the process of treatment. Such attitude towards emotional suppression is thriving well in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing proclivity.

While recognizing the methodological hurdles in discerning and gauging such concepts of emotional suppression , it remains pivotal to delve into interventions to help breast cancer survivors to navigate through these challenges resulting from lengthy process of investigation and treatment. Several psychotherapeutic interventions were tested including Expressive Writing. Expressive Writing is one type of intervention aimed at improving emotion regulation through emotional disclosure. According to the expressive writing intervention (EWI) paradigm, it may be possible to improve both mental and physical health through improving self-regulation of emotion-related experiences.

Many mechanisms have been put forward to explicate the effects of Expressive Writing. Expressive writing may decrease individuals' distress by improving self-regulation of emotions, behaviors, and physiological responses. In some way, expressive writings help the person to connect thoughts to feelings. Furthermore, modulating autonomic arousal to cancer related thoughts and feelings and cognitive processing of events into a coherent and meaningful narrative have been suggested as mechanisms leading to desirable effect of EW. According to the social integration model, expressive writing might encourage individuals to seek social support, which, in turn, feeds in their psychological well-being. In 1986, Pennebaker for the first time used Expressive writing (EW), which a brief emotional disclosure experiment, with college students. st Pennebaker's paradigm for EW experiment encouraged participants to disclose in writing about their trauma-related personally distressing thoughts and feelings for 20 min over four consecutive days and had another group to write about neutral topic. Emotional disclosure arm had shown enhanced well-being and fewer medical visits following writing compared to those who wrote about neutral topics. Pennebaker and Beall (1986) found that EW is a potentially effective intervention which was later tested on various population and settings including, clinically ill patients and healthy individuals. , , .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Omani Women Having a breast cancer diagnosis stage, I and II
  • Completing breast cancer surgery within 5 years
  • Subsequently received adjuvant treatment including chemotherapy, hormonal treatment, or Radiation therapy
  • Being comfortable writing and speaking in Arabic Or English

排除标准

  • Nonconsenting
  • Presence of severe physical illness
  • Diagnoses with severe Mental or intellectual disorder
  • Advanced breast cancer
  • Un able to comply with trial protocol
  • Presence of another cancer diagnoses

结局指标

主要结局

The difference in the mean scores of Functional Assessment of Cancer Therapy general scale: FACT-G V4

时间窗: 1-3 MONTHS

This 27-item measure examines the perceived quality of life across four dimensions including physical, social, emotional, and functional well-being in the past week. Each item is rated from (0) not at all to (4) very much. The scores of physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items) subscales range of 0-28, 0-28, 0-24, and 0-28, respectively. The highest score of that could be obtained on FACT-G is 108 where the highest the scores the better the quality of life of the patient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Al Alawi

Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD, MRCPsych, OMSBPsych, ARABPsych

Sultan Qaboos University

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