Writing About Experiences With Ovarian Cancer

Sponsor

University of Maryland, College Park (Other)

Overall Status

Completed

CT.gov ID

NCT02593422

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Behavioral: Expressive Writing Behavioral: Fact Writing (Control)	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Psychological Functioning (Wellbeing/Distress) [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

Change in Physical Wellbeing [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).
Changes in affect before and after writing about ovarian cancer [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, College Park	College Park	Maryland	United States	20742

Sponsors and Collaborators

University of Maryland, College Park

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Maryland, College Park

ClinicalTrials.gov Identifier:

NCT02593422

Other Study ID Numbers:

728101-3

First Posted:

Nov 1, 2015

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Keywords provided by University of Maryland, College Park

ovarian cancer

expressive writing

writing interventions

psychosocial support

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of May 23, 2022