Clinical trial NCT01784406: Person-centred Support for Women After Treatment for Gynaecological Cancer
Official title: Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Female Reproductive System Neoplasm
Follow-up
Supportive Care
Psychosocial Circumstances
Survivorship
Keywords: Self-management intervention
Psychosocial care
Autonomy-supportive
Gynaecological cancer survivors
Guided self-Determination
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
timeFrame: 9 months after randomisation
Secondary outcomes:
measure: Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)
timeFrame: 3 months after randomisation
measure: Changes in Quality of life in the two groups
timeFrame: 9 months
measure: Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)
timeFrame: 3 and 9 months after randomisation
measure: Self-esteem measured by Rosenbergs Self Esteem Scale
timeFrame: 3 and 9 months after randomisation
measure: Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 and 9 months from randomisation
measure: Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)
timeFrame: 3 and 9 months from randomisation
measure: Distress measured by Distress Thermometer(DT).
timeFrame: 3 and 9 months from randomisation
measure: Symptom monitoring and recognition
timeFrame: 3 and 9 months after randomisation (+/- one week for practical reasons)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet
state: Copenhagen Ø
Study officials:
References: