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NCT04843358
Efficacy of Expressive Writing on Quality of Life Among Breast Cancer Survivors in Oman: A Double Blind Randomized Controlled Trial
NA trial testing Emotional Disclosure in Breast Cancer in 64 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Sultan Qaboos University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 64 |
| Start date | 1 January 2022 |
| Primary completion | 1 January 2024 |
| Estimated completion | 30 December 2024 |
Drugs / interventions tested
- Emotional Disclosure
- Non-Emotional Writing
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Quality of Life — all drugs for Quality of Life →
- Expressive Writing — all drugs for Expressive Writing →
- Psychological — all drugs for Psychological →
Sponsor
Sultan Qaboos University
Who can join
Adults 18 to 60, female only, with Breast Cancer or Quality of Life. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04843358
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Other Sultan Qaboos University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04843358 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sultan Qaboos University
- Last refreshed: 26 April 2021
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