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

NCT04843358 | Unknown DMC

• 1 other identifier: 14/2021
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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

  1-3 MONTHS

Study Arms (2)

Emotional Disclosure

EXPERIMENTAL

Participants in the emotional disclosure arm will be told to write continuously for 20 min about their deepest thoughts and feelings regarding their breast cancer experience

Behavioral: Emotional Disclosure

Non-Emotional Writing

ACTIVE COMPARATOR

Participant allocated to the control group will be asked to describe in detail their daily activities in a non-emotional manner in accord with Pennebaker's published instructions

Behavioral: Non-Emotional Writing

Interventions

Emotional Disclosure BEHAVIORAL

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."

Emotional Disclosure

Non-Emotional Writing BEHAVIORAL

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

Non-Emotional Writing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohammed S Al-Alawi, MD

CONTACT

92281145; alalawim@squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD, MRCPsych, OMSBPsych, ARABPsych

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 30, 2024
• Last Updated: April 26, 2021

Record last verified: 2021-04