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Trial registered on ANZCTR


Registration number
ACTRN12615000213549
Ethics application status
Approved
Date submitted
20/02/2015
Date registered
5/03/2015
Date last updated
4/12/2019
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness Based Cognitive Therapy for Fear of Recurrence in Ovarian Cancer Survivors. (FROCS)
Scientific title
Mindfulness Based Cognitive Therapy for Fear of Recurrence in Ovarian Cancer Survivors. (FROCS)
Secondary ID [1] 286229 0
None
Universal Trial Number (UTN)
Trial acronym
FROCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of recurrence. 294274 0
Ovarian Cancer 294275 0
Condition category
Condition code
Cancer 294596 294596 0 0
Ovarian and primary peritoneal
Mental Health 294665 294665 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness Based Cognitive Therapy.
Mindfulness based cognitive therapy is a group program that is generally used to delay or prevent recurrence of major depression, but may also reduce depressive symptoms. The treatment combines the clinical application of mindfulness meditation with elements of cognitive-behavioral therapy, and was first developed in 2000.
Mindfulness is purposeful, nonjudgmental attention to the present moment, which is developed through meditation and other practices. CBT is based upon the theory that maladaptive thoughts and behaviors lead to psychopathology; the clinician and patient identify these dysfunctional cognitions and the patient tries to change the resulting problematic behaviors.
There are similarities between mindfulness based cognitive therapy and CBT. Both treatments teach patients to identify triggers and symptoms of relapse such as anxiety and depression, and to develop a behavior plan for avoiding relapse. Other similarities include directing patients to observe their thoughts and to rate activities for the pleasure and sense of mastery they provide.
What distinguishes mindfulness based cognitive therapy is its emphasis upon accepting dysfunctional thoughts. In contrast, CBT emphasizes changing dysfunctional thoughts by gathering evidence to dispute their validity.
The MBCT course comprises 8 weekly sessions with each session being approximately 2 hours. The duration of the course is 8 weeks and the sessions take place in groups of 8-15 individuals. The groups will be run by experienced clinicians in psychotherapy, counselling and meditation and will have a clinician manual and a participant workbook outlining the themes and exercises for each week. Adherence is monitored by discussion of issues which may arise during practice of the techniques in between sessions.
Intervention code [1] 291247 0
Treatment: Other
Intervention code [2] 291300 0
Behaviour
Comparator / control treatment
There is no control group as this is a pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294368 0
Fear of Ovarian Cancer Recurrence.
Fear of Cancer Recurrence is assessed using the 42-item FCRI, the most comprehensive multi-dimensional scale of FCR available, and suitable for patients with mixed cancer diagnoses. It has been found to be internally consistent (Chronbach’s a=0.75 to 0.91 across subscales) and stable over a two-week interval (query = 0.58 to 0.83 across subscales), and has a robust factor structure. The FCRI has convergent validity with other standardised measures of FCR and discriminant validity with QOL amongst a large sample (n = 600) of Canadian cancer patients with mixed tumours. Respondents rate the degree to which symptoms or issues affect them on a Likert scale ranging from 0 (‘not at all’ or ‘never’) to 4 (‘a great deal’ or ‘all the time’). Higher scores indicate higher FCR.
Timepoint [1] 294368 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [1] 313111 0
General distress which will be assessed with the Hospital Anxiety, Depression Stress Scale.



Timepoint [1] 313111 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention
Secondary outcome [2] 313112 0
Mindfulness.
This will be measured using the Freiburg Mindfulness Inventory.
Timepoint [2] 313112 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [3] 313113 0
Physical well-being.
This will be measured using the Physical Assessment Scale.
Timepoint [3] 313113 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [4] 313114 0
Rumination.
This will be measured using the Ruminative Response Scale.
Timepoint [4] 313114 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [5] 313115 0
Perseveration.
This will be measured using the Perseverative Thinking Questionnaire.
Timepoint [5] 313115 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [6] 313116 0
The impact of the disease on the participant.
This will be measured using the Impact of Event Scale.
Timepoint [6] 313116 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.
Secondary outcome [7] 313117 0
Past distress.
This will be measured using the Assessment of past distress scale.
Timepoint [7] 313117 0
Immediately prior to the first MBCT group class, at the conclusion of the MBCT course and 6 months after completion of the MBCT intervention.

Eligibility
Key inclusion criteria
- Have a confirmed diagnosis of primary or recurrent epithelial ovarian carcinoma (any histopathological subtype and any stage of disease at diagnosis)
- Are being treated with curative intent
- Have completed all hospital-based adjuvant treatments
- Are disease-free
- Are fluent in English
- Are over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Germ cell or stromal tumours
- Currently have severe major depression with suicidal ideation
- Are currently receiving psychological treatment
- Currently have active psychotic illness or psychiatric/cognitive condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be invited to participate in this study at their routine follow up appointments in the private consulting rooms of three gynaecologic oncologists who are accredited at St John of God Hospitals in Subiaco and Murdoch, WA. Eligible patients will be approached in the waiting room by a clinical trial manager who will provide written and verbal information about the study. Patients who wish to participate will be asked to give their informed consent by signing a written consent form. Patients attending the Gynaecologic Oncology Outpatient Clinic at King Edward Memorial Hospital will also be invited to participate in the study by a Senior Social Worker/Research Assistant who will perform a similar role as the clinical trial manager in the private sector.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)
WA
Recruitment hospital [1] 3494 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 3495 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 9262 0
6008 - Subiaco
Recruitment postcode(s) [2] 9263 0
6008 - Subiaco East

Funding & Sponsors
Funding source category [1] 290790 0
Hospital
Name [1] 290790 0
St John of God Hospital Subiaco
Address [1] 290790 0
12 Salvado Road
Subiaco
WA 6008
Country [1] 290790 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Cohen
Address
Director of Gynaecological Cancer Research
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 289473 0
Charities/Societies/Foundations
Name [1] 289473 0
SolarisCare Foundation
Address [1] 289473 0
Sir Charles Gairdner Hospital
DD Block Ground Floor,
Hospital Avenue
Nedlands WA 6009
Country [1] 289473 0
Australia
Secondary sponsor category [2] 289570 0
Charities/Societies/Foundations
Name [2] 289570 0
Cancer Council WA
Address [2] 289570 0
46 Ventnor Avenue
West Perth
WA 6005
Country [2] 289570 0
Australia
Other collaborator category [1] 278362 0
University
Name [1] 278362 0
Schools of Surgery and Behavioral Science
University of Western Australia
Address [1] 278362 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country [1] 278362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292420 0
St John of God Health Care Subiaco
Ethics committee address [1] 292420 0
12 Salvado Road
Subiaco
WA 6008
Ethics committee country [1] 292420 0
Australia
Date submitted for ethics approval [1] 292420 0
Approval date [1] 292420 0
11/02/2015
Ethics approval number [1] 292420 0
769

Summary
Brief summary
This study will determine the effect of mindfulness based cognitive therapy on the fear of recurrence in ovarian cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with ovarian cancer, have completed all hospital based adjuvant treatment and are now disease free. Study details All participants will receive the same intervention and will involve intensive training and practice in mindfulness based cognitive therapy. Treatment is designed as an 8 week course of 2-2.5 hour small group sessions once weekly with approximately 8-15 individuals in each group. Sessions are run at locations in Shenton Park, Duncraig and East Fremantle by the Cancer Council WA, or by SolarisCare Foundation, at Sir Charles Gardner Hospital in Nedlands. Courses take place during the day and are free of charge. The groups will be run by experienced clinicians in psychotherapy, counselling and meditation and will have a clinician manual and a participant workbook outlining the themes and exercises for each week. Group members will be expected to practice skills between sessions. Participants will be asked to answer questionnaires before, during and after the group sessions to collect information on how participants are feeling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55186 0
Dr Paul Cohen
Address 55186 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 55186 0
Australia
Phone 55186 0
+ 61 8 9382 4292
Fax 55186 0
Email 55186 0
paul.cohen@uwa.edu.au
Contact person for public queries
Name 55187 0
Dr Paul Cohen
Address 55187 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 55187 0
Australia
Phone 55187 0
+61 8 9382 4292
Fax 55187 0
Email 55187 0
paul.cohen@uwa.edu.au
Contact person for scientific queries
Name 55188 0
Dr Paul Cohen
Address 55188 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 55188 0
Australia
Phone 55188 0
+61 8 9382 4292
Fax 55188 0
Email 55188 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
Not applicable.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Results not yet available