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

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ClinicalTrials.gov Identifier: NCT01638741
Recruitment Status : Unknown
Verified April 2013 by Kamila Adellund Holt, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2012
Last Update Posted : April 24, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer
Study Start Date : September 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kamila Adellund Holt, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01638741     History of Changes
Other Study ID Numbers: Rehabilitation
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013