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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784406
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):
Mette Linnet Olesen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Malignant Female Reproductive System Neoplasm Follow-up Supportive Care Psychosocial Circumstances Survivorship Behavioral: Autonomy supportive counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS) [ Time Frame: 9 months after randomisation ]
    +/- one week for practical reasons

Secondary Outcome Measures :
  1. Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS) [ Time Frame: 3 months after randomisation ]
    +/- one week for practical reasons

  2. Changes in Quality of life in the two groups [ Time Frame: 9 months ]
    Quality of life at 9 months minus the quality of life at the time of randomisation.

  3. Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2) [ Time Frame: 3 and 9 months after randomisation ]
    +/- one week for practical reasons

  4. Self-esteem measured by Rosenbergs Self Esteem Scale [ Time Frame: 3 and 9 months after randomisation ]
    +/- one week for practical reasons

  5. Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 9 months from randomisation ]

    Also used as screening instrument baseline.

    +/- one week for practical reasons

  6. Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ) [ Time Frame: 3 and 9 months from randomisation ]
    +/- one week for practical reasons

  7. Distress measured by Distress Thermometer(DT). [ Time Frame: 3 and 9 months from randomisation ]

    Also used as screening instrument baseline.

    +/- one week for practical reasons.

  8. Symptom monitoring and recognition [ Time Frame: 3 and 9 months after randomisation (+/- one week for practical reasons) ]
    Womens ability to know what symptoms to monitor and react to in case of recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01784406

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Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Additional Information:
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Responsible Party: Mette Linnet Olesen, Ph.d student, Rigshospitalet, Denmark Identifier: NCT01784406     History of Changes
Other Study ID Numbers: H-4-2012-FSP(94)
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Mette Linnet Olesen, Rigshospitalet, Denmark:
Self-management intervention
Psychosocial care
Gynaecological cancer survivors
Guided self-Determination
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site