Person-centred Support for Women After Treatment for Gynaecological Cancer

Survivorship Clinical Trial

— PESU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784406
• Other study ID #: H-4-2012-FSP(94)
• Status: Completed
• Phase: N/A
• First received: February 3, 2013
• Last updated: January 14, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Capital Region of Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Follow-up
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Psychosocial Circumstances
• Supportive Care
• Survivorship

Intervention

Behavioral:
• Autonomy supportive counselling

Locations

Country	Name	City	State
Denmark	Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet	Copenhagen	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)	+/- one week for practical reasons	3 months after randomisation	No
Secondary	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	No
Secondary	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	No
Secondary	Self-esteem measured by Rosenbergs Self Esteem Scale	+/- one week for practical reasons	3 and 9 months after randomisation	No
Secondary	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	No
Secondary	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	No
Secondary	Distress measured by Distress Thermometer(DT).	Also used as screening instrument baseline.; +/- one week for practical reasons.	3 and 9 months from randomisation	No
Secondary	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)	No

External Links

•   Copenhagen University Hospital, Rigshospitalet has changed to a new web system therefore a new url adress/Statistical analysis plan