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Writing About Experiences With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02593422
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Expressive Writing Behavioral: Fact Writing (Control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Writing About Experiences With Ovarian Cancer
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593422


Locations
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United States, Maryland
University of Maryland, College Park
College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Study Chair: Mary Ann Hoffman, Ph.D. University of Maryland, College Park

Publications:
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Responsible Party: University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02593422     History of Changes
Other Study ID Numbers: 728101-3
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Keywords provided by University of Maryland, College Park:
ovarian cancer
expressive writing
writing interventions
psychosocial support
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma