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

This study is currently recruiting participants.
Verified February 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Mette Linnet Olesen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01784406
First received: February 3, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Malignant Female Reproductive System Neoplasm
Follow-up
Supportive Care
Psychosocial Circumstances
Survivorship
 Behavioral: Autonomy supportive counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS) [ Time Frame: 9 months after randomisation ] [ Designated as safety issue: No ]
    +/- one week for practical reasons


Secondary Outcome Measures:
  • Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS) [ Time Frame: 3 months after randomisation ] [ Designated as safety issue: No ]
    +/- one week for practical reasons

  • Changes in Quality of life in the two groups [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 and 9 months after randomisation ] [ Designated as safety issue: No ]
    +/- one week for practical reasons

  • Self-esteem measured by Rosenbergs Self Esteem Scale [ Time Frame: 3 and 9 months after randomisation ] [ Designated as safety issue: No ]
    +/- one week for practical reasons

  • Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 9 months from randomisation ] [ Designated as safety issue: No ]

    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) [ Time Frame: 3 and 9 months from randomisation ] [ Designated as safety issue: No ]
    +/- one week for practical reasons

  • Distress measured by Distress Thermometer(DT). [ Time Frame: 3 and 9 months from randomisation ] [ Designated as safety issue: No ]

    Also used as screening instrument baseline.

    +/- one week for practical reasons.



Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autonomy-supportive counselling
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.
 Behavioral: Autonomy supportive counselling
No Intervention: Control
Standard of care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784406

Contacts
Contact: Mette L Olesen, Ph.d student +45 35 45 68 50 mette.linnet.olesen@regionh.dk

Locations
Denmark
Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Mette L Olesen, Ph.d stud     +45 35 45 68 50     mette.linnet.olesen@regionh.dk    
Principal Investigator: Mette L Olesen, Ph.d. stud            
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Mette Linnet Olesen, Ph.d student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01784406     History of Changes
Other Study ID Numbers: H-4-2012-FSP(94)
Study First Received: February 3, 2013
Last Updated: February 4, 2013
Health Authority: Denmark: The Capital Region of Denmark

Keywords provided by Rigshospitalet, Denmark:
Self-management intervention
Psychosocial care
Autonomy-supportive
Gynaecological cancer survivors
Guided self-Determination

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013