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

Summary

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.

Conditions

• Breast Cancer
• Quality of Life
• Expressive Writing
• Psychological

Interventions

BEHAVIORAL

Emotional Disclosure

The trial member will deliver instructions "For the next three days, I want you to write about your experience with cancer. In your writing, I want you to really let go and explore your very deepest emotions and thoughts. It is critical that you delve deeply. Ideally, I would like you to write about those parts of the experience you found hard to share with others. Perhaps this will provide an opportunity to really examine those thoughts and emotions. You might tie your personal experiences to other parts of your life. How is it related to your family life, relationship with your spouse, your children, your sexuality, daily activities, hobbies, your past, your childhood, your work? These are just some examples."

BEHAVIORAL

Non-Emotional Writing

The trial member will deliver instructions were as follows." For the next three days, I want you to write about how you use your time. We are interested in everything you do during the course of a day. In your writing I want you to be completely objective. We are not interested in your emotions or opinions. Feel free to be as detailed as possible

Sponsors & Collaborators

• Sultan Qaboos University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2024-01-01

Completion

2024-12-30