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Person-centred Support for Women After Treatment for Gynaecological Cancer (PESU)

Primary Purpose

Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Autonomy supportive counselling
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Female Reproductive System Neoplasm focused on measuring Self-management intervention, Psychosocial care, Autonomy-supportive, Gynaecological cancer survivors, Guided self-Determination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Autonomy-supportive counselling

Control

Arm Description

2-4 autonomy-supportive conversations with an experienced nurse, educated both theoretically and practically in the method Guided Self-Determination that includes specific "reflection sheets" and use of advanced communication; in addition to standard care.

Standard of care.

Outcomes

Primary Outcome Measures

Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
+/- one week for practical reasons

Secondary Outcome Measures

Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)
+/- one week for practical reasons
Changes in Quality of life in the two groups
Quality of life at 9 months minus the quality of life at the time of randomisation.
Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)
+/- one week for practical reasons
Self-esteem measured by Rosenbergs Self Esteem Scale
+/- one week for practical reasons
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Also used as screening instrument baseline. +/- one week for practical reasons
Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)
+/- one week for practical reasons
Distress measured by Distress Thermometer(DT).
Also used as screening instrument baseline. +/- one week for practical reasons.
Symptom monitoring and recognition
Womens ability to know what symptoms to monitor and react to in case of recurrence

Full Information

First Posted
February 3, 2013
Last Updated
January 14, 2016
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01784406
Brief Title
Person-centred Support for Women After Treatment for Gynaecological Cancer
Acronym
PESU
Official Title
Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled. The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship
Keywords
Self-management intervention, Psychosocial care, Autonomy-supportive, Gynaecological cancer survivors, Guided self-Determination

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autonomy-supportive counselling
Arm Type
Experimental
Arm Description
2-4 autonomy-supportive conversations with an experienced nurse, educated both theoretically and practically in the method Guided Self-Determination that includes specific "reflection sheets" and use of advanced communication; in addition to standard care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Autonomy supportive counselling
Primary Outcome Measure Information:
Title
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
Description
+/- one week for practical reasons
Time Frame
9 months after randomisation
Secondary Outcome Measure Information:
Title
Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)
Description
+/- one week for practical reasons
Time Frame
3 months after randomisation
Title
Changes in Quality of life in the two groups
Description
Quality of life at 9 months minus the quality of life at the time of randomisation.
Time Frame
9 months
Title
Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)
Description
+/- one week for practical reasons
Time Frame
3 and 9 months after randomisation
Title
Self-esteem measured by Rosenbergs Self Esteem Scale
Description
+/- one week for practical reasons
Time Frame
3 and 9 months after randomisation
Title
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Description
Also used as screening instrument baseline. +/- one week for practical reasons
Time Frame
3 and 9 months from randomisation
Title
Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)
Description
+/- one week for practical reasons
Time Frame
3 and 9 months from randomisation
Title
Distress measured by Distress Thermometer(DT).
Description
Also used as screening instrument baseline. +/- one week for practical reasons.
Time Frame
3 and 9 months from randomisation
Title
Symptom monitoring and recognition
Description
Womens ability to know what symptoms to monitor and react to in case of recurrence
Time Frame
3 and 9 months after randomisation (+/- one week for practical reasons)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Person-centred Support for Women After Treatment for Gynaecological Cancer

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