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Trial registered on ANZCTR


Registration number
ACTRN12620000332921
Ethics application status
Approved
Date submitted
21/01/2020
Date registered
10/03/2020
Date last updated
10/09/2020
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Getting the MOST out of Ovarian Cancer Follow-up using a nurse led telephone intervention
Scientific title
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.
Secondary ID [1] 300276 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
MOST
Linked study record
N/a

Health condition
Health condition(s) or problem(s) studied:
Epithelial tubal-ovarian cancer 315855 0
Emotional wellbeing of patients diagnosed with ovarian cancer 316102 0
Condition category
Condition code
Cancer 314136 314136 0 0
Ovarian and primary peritoneal
Mental Health 314387 314387 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 316550 0
Treatment: Other
Comparator / control treatment
Control group - If patients are randomised into a control group they are provided standard of care and will attend their regular clinic for consultation with their treating physician every three months. If they are on maintenance therapy they may be required to be seen more regularly one monthly initially then three monthly once the patient is stabilised, however this will be at the discretion of the specialist. Patients in the control group will also be required to complete the MOST question prior to each follow up visit.
Control group
Active

Outcomes
Primary outcome [1] 322565 0
Outcome:
The primary composite outcome is to assess the feasibility, acceptability and safety of this new type of follow-up intervention compared to conventional hospital clinic-based follow-up that includes completion of the MOST. Feasibility will be assessed by the proportions of patients randomised to the intervention who comply with the intervention and who withdraw or cross-over to the control arm. Acceptability will be assessed by the EORTC outpatient satisfaction with care questionnaire (EORTC OUTPATSAT-7) and by the qualitative sub-study that will conduct interviews with a subset of 30 patients and the study nurses. Safety will be assessed by the time to recurrence in each group. The intervention will be considered safe if there is no delay in diagnosing recurrence in the intervention group compared to routine care (i.e. no difference in time to recurrence between the intervention and control groups).
The Intervention involves a nurse led video call run for approximately 45 minutes, three monthly, and completion of the MOST (Measure of Ovarian Symptoms and Treatment) questionnaire, compared to conventional hospital clinic-based follow-ups that will also include completion of the MOST questionnaire.
Timepoint [1] 322565 0

Primary time point: feasibility and acceptability will be assessed 24 months post study intervention commencement. The intervention will consist of three-monthly remote interviews for 24 months post intervention commencement.

Secondary outcome [1] 378955 0
Healthcare resource use, costs and cost-effectiveness of the intervention.

A within-trial cost-utility analysis will be performed from an Australian Government health system perspective. The incremental costs and incremental benefits of remote nurse-led telephone follow-up at 12 months after randomisation compared with usual care follow-up, will be calculated for trial patients. The within-trial economic analysis will be performed using individual patient level data from the MOST trial. The analytical approach will take the form of a cost-utility analysis. Based on trial evidence, incremental cost-effectiveness (cost-utility) ratios will be calculated by taking a ratio of the difference in the mean costs and mean effects (utility measure). Benefits will be measured in quality-adjusted life years (QALYs). The quality-adjustment will be determined using the validated EORTC QLU-C10D instrument that transforms self-reported scores from the QLQ-C30 questionnaire into preference weights or utilities. These utilities will represent patients' overall quality of life and be multiplied by the time spent in each state to generate QALYs. An appropriate regression model will be used to adjust for any imbalance in baseline utility (however small) and the minimisation variables of the randomisation process.

Healthcare resource use will be identified and measured every 3 months until 12 months post-randomisation using trial CRFs, completed by trial nurses and data managers. At the end of the trial, resource use will be verified through linkage to the MBS and PBS. All resource use will be valued in monetary terms using appropriate Australian unit costs or patient valuations estimated at the time of analysis (2020-2021). Adjustments will be made for inflation if necessary, using the AIHW GDP deflator index. Reference costs will be employed to value hospital resource use (e.g. Net Efficient Price and National Weighted Activity Units (NWAUs). Outpatient costs will be valued using cost weights for the MBS and PBS in the most recent year.

Costs and benefits will not be discounted due to the 12-month time horizon.
The estimated mean QALYs and costs associated with each treatment option will be combined with a feasible range of values for decision makers' willingness to pay (?), to obtain distribution of net benefits at different levels of ?. The primary economic analysis will present results using an arbitrary cost-effectiveness threshold of $50,000 per QALY gained. Cost and QALY data will be combined to calculate an incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB) statistic from an Australian health system perspective.

The nonparametric bootstrapping approach will be used to determine the level of sampling uncertainty surrounding the mean ICER by generating 10,000 estimates of incremental costs and benefits. Several sensitivity analyses will be undertaken to explore uncertainties surrounding key parameters in the economic evaluation. The results for complete cost and quality of life data (i.e. those with no missing data) as well as a strict per-protocol analysis of the data will be provided to identify the impact of missing data on the analysis and any sensitivity to protocol violations. The economic analysis will be reported according to best practice guidelines.

Timepoint [1] 378955 0
Healthcare resource use will be identified and measured every 3 months until 12 months post-randomisation using trial Case report forms.
Secondary outcome [2] 380659 0
Proportion of patients in both the intervention arm (nurse-led follow-up group) and standard care arm who completed the MOST prior to their follow-up consultation
Timepoint [2] 380659 0
Completed at baseline, 3,6,9,12,15,18,21 and 24 months
Secondary outcome [3] 380660 0
Proportion of patients in the intervention arm who crossed over to the standard care arm
Timepoint [3] 380660 0
Up to 24 months
Secondary outcome [4] 380661 0
The duration of the nurse-led follow-up consultations
Timepoint [4] 380661 0
Up to 24 months
Secondary outcome [5] 380662 0
The number of referrals for symptom management generated in both arms
Timepoint [5] 380662 0
Up to 24 months
Secondary outcome [6] 380663 0
The outcomes of these referrals - whether the patient attended, what treatment was recommended, and whether the patient adhered to the recommended treatment
Timepoint [6] 380663 0
Up to 24 months
Secondary outcome [7] 380664 0
Patient satisfaction (CANHELP Lite and EORTC OUTPATSAT-7)
Timepoint [7] 380664 0
Questionnaires completed at base line, 6, 12 and 24 months
Secondary outcome [8] 380665 0
HRQL European (Organisation for Research and Treatment of Cancer core quality of life questionnaire, EORTC QLQ-C30)
Timepoint [8] 380665 0
Questionnaires completed at base line, 6, 12 and 24 months
Secondary outcome [9] 380666 0
Fear of recurrence Fear of Cancer Recurrence Inventory Severity subscale
Timepoint [9] 380666 0
Up to 24 months
Secondary outcome [10] 380668 0
Preference-based HRQL utility scores derived from QLQ-C30 responses using Australian utility weights for the EORTC multi-attribute utility instrument QLU-C10D
Timepoint [10] 380668 0
Questionnaires completed at base line, 6, 12 and 24 months
Secondary outcome [11] 380669 0
Recurrence detection rates in each arm.

Recurrence is suggested by a serum CA125 above twice the upper limit of normal (>70kU/L) and defined as new measurable disease on CT or PET-CT scan.
Timepoint [11] 380669 0
Up to 24 months
Secondary outcome [12] 380670 0
Time to first recurrence and method of diagnosis

Time to first recurrence is defined as the time in months from the date of diagnosis to the date of recurrence confirmed by imaging (CT or PET-CT scan).
Timepoint [12] 380670 0
Up to 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
150 patients will be recruited and randomised 1:1 (Intervention or control). Following randomisation, patients will be assigned to the intervention group (the nurse-led follow-ups) or the control group (routine clinic visits) by a study coordinator at each site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study will be analyzed according to the intention-to-treat principle. The proportion of patients in the intervention and control arms will be compared in an unadjusted analysis using a chi-square test for the following outcomes: normalization of emotional wellbeing (defined as a score of 20 or more on the FACT-O4) at 6, 12, 18 and 24 months; completion of the MOST prior to the follow-up consultations; referrals generated for symptom management and the outcomes of these referrals; patient satisfaction; and fear of recurrence. Time to first recurrence in each arm will be compared using Kaplan Meier survival curves and the log rank test. Exploratory analyses will also be performed using appropriate multiple regression methods (linear, logistic) to examine the impact of baseline variables on outcomes. Exploratory analyses will determine the pattern of missingness in PRO data (i.e. missing at random, missing not at random) and appropriate imputation methods applied.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 15639 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [2] 15640 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 15641 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 15642 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 15643 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [6] 15644 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [7] 15646 0
Prince of Wales Hospital - Randwick
Recruitment hospital [8] 15647 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [9] 15648 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 15649 0
The Royal Women's Hospital - Parkville
Recruitment hospital [11] 15663 0
Buderim Private Hospital - Buderim
Recruitment postcode(s) [1] 29048 0
6008 - Subiaco
Recruitment postcode(s) [2] 29049 0
6009 - Nedlands
Recruitment postcode(s) [3] 29050 0
6008 - Subiaco East
Recruitment postcode(s) [4] 29051 0
4029 - Herston
Recruitment postcode(s) [5] 29052 0
4120 - Greenslopes
Recruitment postcode(s) [6] 29053 0
4000 - Brisbane
Recruitment postcode(s) [7] 29055 0
2031 - Randwick
Recruitment postcode(s) [8] 29056 0
2050 - Camperdown
Recruitment postcode(s) [9] 29057 0
3000 - Melbourne
Recruitment postcode(s) [10] 29058 0
3052 - Parkville
Recruitment postcode(s) [11] 29072 0
4556 - Buderim

Funding & Sponsors
Funding source category [1] 304700 0
Other Collaborative groups
Name [1] 304700 0
The Western Australian Health Translation Network
Address [1] 304700 0
Located in: Harry Perkins Institute of Medical Research
Level 6, 6 Verdun St
NEDLANDS WA 6009

Postal Address: The University of Western Australia,
MBDP M503, WAHTN,
35 Stirling Hwy, Crawley, WA, 6009

T (08) 6151 0887
Country [1] 304700 0
Australia
Funding source category [2] 304735 0
Government body
Name [2] 304735 0
The Australian Government’s Medical Research Future Fund (MRFF)
Address [2] 304735 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [2] 304735 0
Australia
Funding source category [3] 304736 0
Other Collaborative groups
Name [3] 304736 0
The Ladybird Foundation
Address [3] 304736 0
Po Box 820
South Perth WA 6951.
Australia
Country [3] 304736 0
Australia
Funding source category [4] 304737 0
Other Collaborative groups
Name [4] 304737 0
Australia and New Zealand Gynaecological Oncology Group Fund for New Research Grant
Address [4] 304737 0
119-143 Missenden Rd,
Camperdown NSW 2050
Country [4] 304737 0
Australia
Primary sponsor type
Hospital
Name
St John of God Subiaco Hospital
Address
12 Salvado Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 305051 0
None
Name [1] 305051 0
NA
Address [1] 305051 0
NA
Country [1] 305051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305118 0
Sir Charles Gardiner Hospital
Ethics committee address [1] 305118 0
Hospital Ave, Nedlands WA 6009
Ethics committee country [1] 305118 0
Australia
Date submitted for ethics approval [1] 305118 0
24/01/2020
Approval date [1] 305118 0
27/03/2020
Ethics approval number [1] 305118 0

Summary
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.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 99330 0
A/Prof Paul Cohen
Address 99330 0
St John of God Subiaco Hospital 12 Salvado Road
Subiaco WA 6008
and
University of Western Australia
Country 99330 0
Australia
Phone 99330 0
+61 406 888 339
Fax 99330 0
NA
Email 99330 0
paul.cohen@uwa.edu.au
Contact person for public queries
Name 99331 0
A/Prof Paul Cohen
Address 99331 0
St John of God Subiaco Hospital 12 Salvado Road
Subiaco WA 6008
and
University of Western Australia
Country 99331 0
Australia
Phone 99331 0
+61 406 888 339
Fax 99331 0
NA
Email 99331 0
paul.cohen@uwa.edu.au
Contact person for scientific queries
Name 99332 0
A/Prof Paul Cohen
Address 99332 0
St John of God Subiaco Hospital 12 Salvado Road
Subiaco WA 6008
and
University of Western Australia
Country 99332 0
Australia
Phone 99332 0
+61 406 888 339
Fax 99332 0
NA
Email 99332 0
paul.cohen@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
N/A
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9128 0
Ethical approval
Citation [1] 9128 0
Link [1] 9128 0
Email [1] 9128 0
Other [1] 9128 0
Summary results
No Results