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

This study is currently recruiting participants.
Verified April 2013 by Odense University Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Odense University Hospital
Information provided by (Responsible Party):
Kamila Adellund Holt, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01638741
First received: May 17, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention
Needs for Rehabilitation
Adult Attachment Style
Quality of Life.
Depression
PTSD
Behavioral: Rehabilitation goals of patients with gynaecological cancer.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Change from baseline in Quality of life at 5 months after surgery. [ Time Frame: at baseline and 5 months after surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in Revised Adult Attachment at 5 months after surgery. [ Time Frame: At baseline and 5 months after sugery ] [ Designated as safety issue: No ]
    Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.

  • Change from baseline in Depression at 5 months after surgery. [ Time Frame: At baseline and 5 months after surgery. ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Posttraumatic stress disorder at 5 months after surgery [ Time Frame: At baseline and 5 months after surgery. ] [ Designated as safety issue: No ]
    To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Rehabilitation goals of patients with gynaecological cancer.
    Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • suspicion of gynaecological cancer
  • surgery for gynaecological cancer

Exclusion Criteria:

  • do not speak Danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638741

Contacts
Contact: Kamila A. Holt, Ph.D. student 0045 26 82 26 57 kamila.holt@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Fyn, Denmark, 5000
Contact: Kamila A. Holt, Ph.D. student    0045 26822657    kamila.holt@rsyd.dk   
Sponsors and Collaborators
Kamila Adellund Holt
University of Southern Denmark
Odense University Hospital
  More Information

No publications provided

Responsible Party: Kamila Adellund Holt, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01638741     History of Changes
Other Study ID Numbers: Rehabilitation
Study First Received: May 17, 2012
Last Updated: April 23, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014