Writing About Experiences With Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive Writing
Fact Writing (Control)
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer focused on measuring ovarian cancer, expressive writing, writing interventions, psychosocial support
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
Sites / Locations
- University of Maryland, College Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Expressive Writing
Fact Writing (Control)
Arm Description
Writing about ovarian cancer: Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
Writing about ovarian cancer: Participants will be asked to write about the facts of their experience with ovarian cancer
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT02593422
First Posted
October 26, 2015
Last Updated
May 16, 2022
Sponsor
University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT02593422
Brief Title
Writing About Experiences With Ovarian Cancer
Official Title
Writing About Experiences With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, expressive writing, writing interventions, psychosocial support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expressive Writing
Arm Type
Experimental
Arm Description
Writing about ovarian cancer: Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
Arm Title
Fact Writing (Control)
Arm Type
Active Comparator
Arm Description
Writing about ovarian cancer: Participants will be asked to write about the facts of their experience with ovarian cancer
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Description
Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
Intervention Type
Behavioral
Intervention Name(s)
Fact Writing (Control)
Intervention Description
Participants will be asked to write about the facts of their experience with ovarian cancer
Primary Outcome Measure Information:
Title
Change in Psychological Functioning (Wellbeing/Distress)
Description
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).
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)
Secondary Outcome Measure Information:
Title
Change in Physical Wellbeing
Description
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).
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)
Title
Changes in affect before and after writing about ovarian cancer
Description
Positive and negative affect will be assessed using the Positive and Negative Affect Scale (PANAS, Watson, Clark & Tellegen, 1988).
Time Frame
Prior to and after each of 4 writing tasks (weeks 1 - 2)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ann Hoffman, Ph.D.
Organizational Affiliation
University of Maryland, College Park
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland, College Park
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25053218
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.
Results Reference
background
PubMed Identifier
17073523
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.
Results Reference
background
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Writing About Experiences With Ovarian Cancer
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