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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014