Clinical trial · Interventional
Person-centred Support for Women After Treatment for Gynaecological Cancer
Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follow-up | — | UNRESOLVED | — |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Psychosocial Circumstances | — | UNRESOLVED | — |
| Supportive Care | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autonomy supportive counselling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autonomy-supportive counselling
- description
- 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.
- interventionNames
- Behavioral: Autonomy supportive counselling
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard of care.
Primary outcomes (1)
- measure
- Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
- timeFrame
- 9 months after randomisation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available