NCT02593422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

October 26, 2015

Last Update Submit

May 16, 2022

Conditions

Ovarian Cancer

Keywords

ovarian cancerexpressive writingwriting interventionspsychosocial support

Outcome Measures

Primary Outcomes (1)

  • 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).

    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 Outcomes (2)

  • 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)

  • Changes in affect before and after writing about ovarian cancer

    Prior to and after each of 4 writing tasks (weeks 1 - 2)

Study Arms (2)

Expressive Writing

EXPERIMENTAL

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

Fact Writing (Control)

ACTIVE COMPARATOR

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

Behavioral: Fact Writing (Control)

Interventions

Expressive WritingBEHAVIORAL

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

Expressive Writing
Fact Writing (Control)BEHAVIORAL

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

Fact Writing (Control)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Minors (younger than 18)
  • Lack of English proficiency
  • Inability to provide informed consent
  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, College Park

College Park, Maryland, 20742, United States

Location

Related Publications (2)

  • 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.

    PMID: 25053218BACKGROUND

  • 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.

    PMID: 17073523BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Mary Ann Hoffman, Ph.D.

    University of Maryland, College Park

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

November 2, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

US(1)