The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer

April 23, 2013 updated by: Kamila Adellund Holt

Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer

The purpose of this study is to provide new knowledge about:

  • Integration of rehabilitation in a highly specialized gynaecological department.
  • Development and testing of an individually adapted rehabilitation process.
  • Needs for rehabilitation among women with gynaecological cancer.
  • Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

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

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:

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

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Study Population Description * Patients referred to Odense University Hospital outpatient clinic with suspition for gynaecological cancer. The patients are from to Regions in Danmark, Region Zealand and Region South Denmark.

Description

Inclusion Criteria:

  • suspicion of gynaecological cancer
  • surgery for gynaecological cancer

Exclusion Criteria:

  • do not speak Danish

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Quality of life at 5 months after surgery.
Time Frame: at baseline and 5 months after surgery
EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix.
at baseline and 5 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Revised Adult Attachment at 5 months after surgery.
Time Frame: At baseline and 5 months after sugery
Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.
At baseline and 5 months after sugery
Change from baseline in Depression at 5 months after surgery.
Time Frame: At baseline and 5 months after surgery.
MDI-12 (Major Depression Inventory), ICD-10 (International Classification of Diseases), measure the depression level in the period from baseline and 5 months after surgery.
At baseline and 5 months after surgery.
Change from baseline in Posttraumatic stress disorder at 5 months after surgery
Time Frame: At baseline and 5 months after surgery.
To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).
At baseline and 5 months after surgery.

Collaborators and Investigators

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

Sponsor

Kamila Adellund Holt

Collaborators

Odense University Hospital
University of Southern Denmark

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

September 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

October 1, 2014

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (ESTIMATE)

July 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Rehabilitation

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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