Person-centred Support for Women After Treatment for Gynaecological Cancer (PESU)
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|ClinicalTrials.gov Identifier: NCT01784406|
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : January 15, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|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|
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: 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
- 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
- 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.
- 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
- Self-esteem measured by Rosenbergs Self Esteem Scale [ Time Frame: 3 and 9 months after randomisation ]+/- one week for practical reasons
- 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
- 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
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01784406
|Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet|
|Copenhagen, Copenhagen Ø, Denmark, 2100|