Clinical trial NCT02593422: Writing About Experiences With Ovarian Cancer
Official title: Writing About Experiences With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: ovarian cancer
expressive writing
writing interventions
psychosocial support
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* Male

Primary outcomes:
measure: Change in Psychological Functioning (Wellbeing/Distress)
timeFrame: 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 outcomes:
measure: Change in Physical Wellbeing
timeFrame: 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)
measure: Changes in affect before and after writing about ovarian cancer
timeFrame: Prior to and after each of 4 writing tasks (weeks 1 - 2)
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Mary Ann Hoffman, Ph.D.
role: STUDY_CHAIR
References:
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.
citation: Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.