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Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial


N/A
18 Years
N/A
Open (Enrolling)
Female
Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship

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Trial Information

Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial


Inclusion Criteria:



- Women only surgically treated for cervix, ovarian (including borderline tumors),
endometrial or vulva cancer, who attend follow up at the Gynaecological Department at
The University Hospital Rigshospitalet in Copenhagen.

- The women should read, write and understand the danish language.

Exclusion criteria:

- Known recurrence.

- Participation in the preliminary pilotstudy.

- Health related problems both physical or psychological, that prevent participation.
For example cognitive impairment, or patients with psychiatric diseases that is
estimated to require nurses with competences within the psychiatric speciality.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)

Outcome Description:

+/- one week for practical reasons

Outcome Time Frame:

9 months after randomisation

Safety Issue:

No

Authority:

Denmark: The Capital Region of Denmark

Study ID:

H-4-2012-FSP(94)

NCT ID:

NCT01784406

Start Date:

January 2013

Completion Date:

February 2015

Related Keywords:

  • Malignant Female Reproductive System Neoplasm
  • Follow-up
  • Supportive Care
  • Psychosocial Circumstances
  • Survivorship
  • Self-management intervention
  • Psychosocial care
  • Autonomy-supportive
  • Gynaecological cancer survivors
  • Guided self-Determination
  • Neoplasms
  • Genital Neoplasms, Female

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