Writing About Experiences With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Writing About Experiences With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593422
• Other study ID #: 728101-3
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This online study aims to understand whether writing about one's experiences with ovarian cancer may be beneficial for psychological and physical wellbeing in women with a history of ovarian cancer. Investigators are also interested in studying how certain individual characteristics may impact the effectiveness of writing. Participants will be asked to complete an initial survey (15 min), followed by writing about their experiences with ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10 min) will be completed one month afterwards.

Description:

The purpose of this randomized controlled experiment is to examine the effects of writing about experiences with ovarian cancer on psychological and physical outcomes in English-speaking women with a history of ovarian cancer. It will also examine how certain individual characteristics may impact the effectiveness of the writing interventions for different women. After completing an initial survey, women will be asked to write about their experiences with ovarian cancer on 4 separate occasions of 20-25 min each in the course of 2 weeks. A final survey will be completed one month after the last writing session. The entire study will be conducted online.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with a history of ovarian cancer (any stage)

• At least 18 years old

• English-speaking/Can comfortably read and write in English

• Able to provide informed consent

• Internet access

• Valid email address

• Any region/country

Exclusion Criteria:

• Minors (younger than 18)

• Lack of English proficiency

• Inability to provide informed consent

• Male

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Expressive Writing
Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
• Fact Writing (Control)
Participants will be asked to write about the facts of their experience with ovarian cancer

Locations

Country	Name	City	State
United States	University of Maryland, College Park	College Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (2)

Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. — View Citation

Merz EL, Fox RS, Malcarne VL. Expressive writing interventions in cancer patients: a systematic review. Health Psychol Rev. 2014;8(3):339-61. doi: 10.1080/17437199.2014.882007. Epub 2014 Feb 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psychological Functioning (Wellbeing/Distress)	Various aspects of social, emotional and functional wellbeing will be assessed using the Functional Assessment of Cancer-Ovarian measure (FACT-O, Version 4, Basen-Engquist et al, 2001). Distress about ovarian cancer will be assessed using the Impact of Event Scale (IES, Horowitz, Wilner & Alvarez, 1979).	6 - 9 weeks, with timely completion of writing: Initial survey (day 1), after 2nd writing task (week 1), after 4th writing task (week 2), and one month after last writing task (week 6)
Secondary	Change in Physical Wellbeing	Physical symptoms and concerns specific to ovarian cancer will be assessed using Functional Assessment of Cancer - Ovarian (FACT-O, Version 4, Basen-Engquist et al, 2001).	6 - 9 weeks, with timely completion of writing: Initial survey (day 1), after 2nd writing task (week 1), after 4th writing task (week 2), and one month after last writing task (week 6)
Secondary	Changes in affect before and after writing about ovarian cancer	Positive and negative affect will be assessed using the Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988).	Prior to and after each of 4 writing tasks (weeks 1 - 2)