Person-centred Support for Women After Treatment for Gynaecological Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship

Intervention / Treatment
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* Behavioral: Autonomy supportive counselling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autonomy-supportive counselling<br>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<br> <br> |
| No Intervention: Control<br>Standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS) | +/- one week for practical reasons | 9 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS) | +/- one week for practical reasons | 3 months after randomisation | 
| 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. | 9 months | 
| Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2) | +/- one week for practical reasons | 3 and 9 months after randomisation | 
| Self-esteem measured by Rosenbergs Self Esteem Scale | +/- one week for practical reasons | 3 and 9 months after randomisation | 
| Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) | Also used as screening instrument baseline. +/- one week for practical reasons | 3 and 9 months from randomisation | 
| Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ) | +/- one week for practical reasons | 3 and 9 months from randomisation | 
| Distress measured by Distress Thermometer(DT). | Also used as screening instrument baseline. +/- one week for practical reasons. | 3 and 9 months from randomisation | 
| Symptom monitoring and recognition | Womens ability to know what symptoms to monitor and react to in case of recurrence | 3 and 9 months after randomisation (+/- one week for practical reasons) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management intervention, Psychosocial care, Autonomy-supportive, Gynaecological cancer survivors, Guided self-Determination