Getting the MOST out of Ovarian Cancer Follow-up using a nurse led telephone intervention
Getting the MOST out of follow-up: a randomised controlled trial to compare three-monthly nurse-led telephone follow-up, including monitoring serum CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic-based follow-up, following completion of first-line chemotherapy in patients with epithelial ovarian cancer.
St John of God Subiaco Hospital
150 participants
Jun 21, 2021
Interventional
Conditions
Summary
The aims of the study is to assess the feasibility of a nurse led intervention in the follow-up of women with ovarian cancer to manage psychosocial symptoms, late effects of treatment and to detect recurrence. Who is it for? You may be eligible for the study if you are 18 years or older and diagnosed with epithelial carcinoma arising from the ovary, Fallopian tube or peritoneum, stages I - IV. Study details You will be randomly allocated (50/50 chance) to the intervention group or control group (standard management with your physician). Participants in the intervention group will be required to answer questions about their cancer symptoms and treatment via the MOST questionnaire. A nurse will use a video call to discuss results of cancer detection blood test and discuss issues around health and financial wellbeing. This video discussion will be around 45 minutes in length. The intervention will run every 3 months for 24 months. If you are currently on maintenance therapy, you will continue as normal to receive care from your oncologist. It is hoped this research can provider greater insight into the Psychosocial support that is required for management of women with ovarian and peritoneum cancers.
Eligibility
Inclusion Criteria6
- Patients diagnosed with epithelial carcinoma arising from the ovary, fallopian tube or peritoneum.
- FIGO stages I - IV
- High grade serous, grade 3 endometrioid and clear cell histotypes
- ECOG Score 0-2
- Normalisation of serum CA125 (to <35kU/L) at completion of first line chemotherapy.
- Age : greater than or equal to 18 years.
Exclusion Criteria3
- Patients who did not undergo cytoreductive surgery
- Patients who did not receive chemotherapy
- An individual assessed as mentally incapable of providing informed consent
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Interventions
Description of Intervention: The intervention will consist of three-monthly remote interviews with a nurse via video call, serum CA125 and completion of the patient-reported MOST questionnaire at home on a personal computer, mobile device or on paper, until recurrence. Participation Duration: 24 months Additional information: 1. Adherence to the intervention - The nurse follow-up appointment will be scheduled in the lead site database with Outlook email calendar reminders to the nurses and patients 1 week before, and 48 hours before, the scheduled follow-up appointment. Blood request forms for CA125 will be provided to the patients at enrolment and they will be reminded to have a blood test by email/SMS at their local pathology provider 1 week prior to the scheduled nurse-led consultation and to complete the MOST PRO tool 3-5 days prior to the consultation. If a patient has not completed the MOST by the time of the appointment, then the nurse will complete it with the patient during the consultation. Patients will be contacted at the arranged time and a structured interview reviewing patients’ MOST responses will be conducted. 2. Study duration for all participants is 24 months. Participants on the maintenance therapy will receive 3 monthly nurse led follow up as well as clinic follow up at the discretion of the oncologist during the 24 month period. 3. CA 125 - CA125 is a glycoprotein that is a marker of ovarian cancer recurrence. Serial CA125 measurement is sensitive and specific for detecting recurrence in the asymptomatic phase. CA125 doubling criteria results in a sensitivity and specificity of 86% and 91% respectively - and its elevation precedes clinical findings by 4–6 months on average. 4. MOST questionnaire - this questionnaire provides a Measure of Ovarian cancer Symptoms and Treatment concerns e.g. abdominal pains, discomfort, abdominal swelling, indigestion, difficulties eating/swallowing, diarrhoea, constipation, tiredness, bladder problems, physical/emotional/general well being, changes in ability to taste, pains in the hands/feet, numbness and tingling, anxiety, depression. 5. Maintenance therapy: - Oral olaparib - twice daily tablet - Avastin (bevacizumab) - IV infusion every 3 weeks
Locations(11)
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ACTRN12620000332921