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NCT Number: NCT02593422

Writing About Experiences With Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, College Park

College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive writing

Behavioral

Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer

Fact Writing (Control)

Behavioral

Participants will be asked to write about the facts of their experience with ovarian cancer

Primary outcomes

  1. 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

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2015
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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