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Clinical Trials/NCT02593422
NCT02593422
Completed
Not Applicable

Writing About Experiences With Ovarian Cancer

University of Maryland, College Park1 site in 1 country73 target enrollmentApril 2015
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
University of Maryland, College Park
Enrollment
73
Locations
1
Primary Endpoint
Change in Psychological Functioning (Wellbeing/Distress)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Psychological Functioning (Wellbeing/Distress)

Time Frame: 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)

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).

Secondary Outcomes

  • Change in Physical Wellbeing(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))
  • Changes in affect before and after writing about ovarian cancer(Prior to and after each of 4 writing tasks (weeks 1 - 2))

Study Sites (1)

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