Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet
Copenhagen, Copenhagen Ø, 2100, Denmark
NCT Number: NCT01784406
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Copenhagen, Copenhagen Ø, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 9 months after randomisation
+/- one week for practical reasons
Time frame: 3 months after randomisation
+/- one week for practical reasons
Time frame: 9 months
Quality of life at 9 months minus the quality of life at the time of randomisation.
Time frame: 3 and 9 months after randomisation
+/- one week for practical reasons
Time frame: 3 and 9 months after randomisation
+/- one week for practical reasons
Time frame: 3 and 9 months from randomisation
Also used as screening instrument baseline.
+/- one week for practical reasons
Time frame: 3 and 9 months from randomisation
+/- one week for practical reasons
Time frame: 3 and 9 months from randomisation
Also used as screening instrument baseline.
+/- one week for practical reasons.
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
Rigshospitalet, Denmark
Other
Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
Acronym: PESU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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