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Status unknownNCT01638741Updated Apr 24, 2013

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

An observational study in Needs for Rehabilitation, Adult Attachment Style and Quality of Life., sponsored by Kamila Adellund Holt. Status unknown at 1 site in Denmark. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-24.

Sponsored by Kamila Adellund Holt · Observational

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
20 Years to 75 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Needs for Rehabilitation
  • Adult Attachment Style
  • Quality of Life.
  • Depression
  • PTSD
03

In context

Lead sponsor

This is the only study on the registry with Kamila Adellund Holt as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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.

Inclusion criteria

  • suspicion of gynaecological cancer
  • surgery for gynaecological cancer

Exclusion criteria

Exclusion Criteria:

  • do not speak Danish
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • BehavioralRehabilitation 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.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Quality of life at 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.

    Time frame: at baseline and 5 months after surgery

Secondary outcomes

  1. Change from baseline in Revised Adult Attachment at 5 months after surgery.

    Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.

    Time frame: At baseline and 5 months after sugery

  2. Change from baseline in Depression at 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.

    Time frame: At baseline and 5 months after surgery.

  3. Change from baseline in Posttraumatic stress disorder at 5 months after surgery

    To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).

    Time frame: At baseline and 5 months after surgery.

07

Study locations

1 of 1 sites recruiting
  • Odense University Hospital
    Odense, Fyn 5000, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01638741
Lead sponsor
Kamila Adellund Holt
Collaborators
University of Southern Denmark, Odense University Hospital
Responsible party
Kamila Adellund Holt (Principal Investigator, Odense University Hospital) — Sponsor-investigator
First posted
Jul 12, 2012
Start date
Sep 2011
Primary completion
Jun 2013 (estimated)
Completion
Oct 2014 (estimated)
Last update
Apr 24, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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