None listed
Conditions
Brief 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.
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 pat
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
Sponsors
St John of God Subiaco Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
Patients who did not undergo cytoreductive surgery Patients who did not receive chemotherapy An individual assessed as mentally incapable of providing informed consent
Outcome results
None listed