Writing About Experiences With Ovarian Cancer

May 16, 2022 updated by: University of Maryland, College Park
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland, College Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expressive Writing
Writing about ovarian cancer: Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
Behavioral: Expressive Writing
Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
Active Comparator: Fact Writing (Control)
Writing about ovarian cancer: Participants will be asked to write about the facts of their experience with ovarian cancer
Behavioral: Fact Writing (Control)
Participants will be asked to write about the facts of their experience with ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Wellbeing
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)
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)
Changes in affect before and after writing about ovarian cancer
Time Frame: Prior to and after each of 4 writing tasks (weeks 1 - 2)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, College Park

Investigators

  • Study Chair: Mary Ann Hoffman, Ph.D., University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 728101-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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