Clinical trial · Interventional
Individualised Versus Conventional Medical Follow-up for Women After Primary Treatment for Ovarian Cancer.
A Randomised Study Comparing Satisfaction With Individualised Follow-up Led by a Trained Cancer Nurse Versus Conventional Medical Follow-up After Primary Treatment for Ovarian Cancer.
NCT02298855CI-TRIAL-00016141completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study in women who have completed primary treatment for ovarian cancer is to investigate the effects of individualised follow-up care delivered by a nurse compared to conventional medical follow-up on quality of life and mood. The investigators aim to determine if the individualised treatment is acceptable to women compared to the conventional treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualised follow-up | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional follow-up
- description
- Treatment as usual will involve: one post treatment appointment then 3 monthly appointments with a Dr. At appointments: medical history; investigations to monitor disease progression including CA125 tumour marker blood test if this were raised at diagnosis. A physical examination may be performed.
- type
- EXPERIMENTAL
- label
- Individualised follow-up
- description
- Follow-up is delivered by a nurse and frequency and type (telephone or face-to-face) is negotiated to suit their individual situation. Assessment by holistic guide. The intervention is informed by a model of health promoting interactions oriented towards improving self-efficacy. The nurses will provide information and support to help patients manage symptoms and psychological discomfort.
- interventionNames
- Behavioral: Individualised follow-up
Primary outcomes (1)
- measure
- The European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire QLQ-C30 with ovarian cancer specific module Ov-28.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Diagnosis of ovarian cancer (includes fallopian tube and peritoneal cancers) 2. Within one month of completion of primary treatment including surgery \& chemotherapy/radiotherapy or surgery alone, irrespective of outcome with regard to remission 3. Expected survival ≥3 months 4. Agreement to be randomised 5. Agreement to give written consent to participate in the study 6. Sufficient grasp of English to engage in the self-management focused approach. Exclusion Criteria 1. A second cancer diagnosis 2. Clinician estimated survival of ≤ 3 months 3. Women receiving treatment for a mental health condition 4. Women who have a learning disability.
References
Publications (3)
- BACKGROUNDGreimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, Holzner B, Kuljanic K, Lebrec J, D'haese S; EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer. 2003 Jul;39(10):1402-8. doi: 10.1016/s0959-8049(03)00307-1. PMID 12826043
- BACKGROUNDKew F, Galaal K, Bryant A, Naik R. Evaluation of follow-up strategies for patients with epithelial ovarian cancer following completion of primary treatment. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD006119. doi: 10.1002/14651858.CD006119.pub2. PMID 21678351
- BACKGROUNDde Bock GH, Bonnema J, van der Hage J, Kievit J, van de Velde CJ. Effectiveness of routine visits and routine tests in detecting isolated locoregional recurrences after treatment for early-stage invasive breast cancer: a meta-analysis and systematic review. J Clin Oncol. 2004 Oct 1;22(19):4010-8. doi: 10.1200/JCO.2004.06.080. PMID 15459225