Gynaecological cancer Cancer
Conditions
Interventions
1. Standard care:
Patients randomised to standard care will continue to have their usual hospital-based doctor-led medical reviews (at 6, and 9 months post-treatment), and will complet
Sponsors
Betsi Cadwaladr University Health Board
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients who have completed treatment for cervical, endometrial, epithelial ovarian, or vulvar cancer within the last 3 months in BCUHB in North Wales 2. Patients who have completed treatment for fallopian tube and primary peritoneal carcinoma 3. Patients will be included if they are considered fit for taking part in the trial and able to give informed consent, as assessed by the multi disciplinary team 4. Patients may have received surgery, chemotherapy, radiotherapy or a combination of these but will not be receiving any continuing treatment that requires hospital care 5. At the time of entry, patients in the view of their treating consultant will not have a definite need for continued hospital care
Exclusion criteria
Exclusion criteria: 1. Patients having had treatment for sarcoma, germ cell tumour, borderline tumours or choriocarcinoma will be excluded as these women tend to require specific and/or more intense follow up often with serial imaging or tumour markers 2. Patients requiring ongoing treatment 3. The study will not include patients who do not have capacity to give informed consent or who are deemed to be unable to take part in the trial (e.g., severe learning/mental disability, severe mental health problems) 4. Patients who are not able to understand Welsh or English
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| A set of study outcome questionnaires will be administered at baseline and at 6 and 9-months post-treatment: 1. EORTC QLQ-C30. This is a validated measure to assess the quality of life of cancer patients 2. EQ-5D-3L. This is a validated generic, health-related, preference-based measure comprising five domains: mobility; self-care; usual activities; pain and discomfort; anxiety and depression 3. ICECAP-A (ICEpop CAPability measure for Adults) is a measure of capability for the general adult population 4. Client Service Receipt Inventory. This is a measure of self-report service user to evaluate and cost service use Additional data to be captured will include: 5. Patient demographics, cancer type and stage, type of treatment received and comorbidity at baseline 6. Data on the pattern, timing and method of detection of relapse and on survival from patient records and routinely captured data sources | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Patient recruitment rate. This will be calculated from the total number of patients invited to take part in the study and the number of patients giving written consent to participate in the study 2. Patient attrition rate. This will be calculated from the number of patients who gave written consent and the number of patients who have completed any measures, regardless of their completion rate | — |
Countries
United Kingdom
Outcome results
None listed