Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000404820
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
11/04/2012
Date last updated
4/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a psychological intervention for fear of cancer recurrence; A longitudinal randomised controlled trial
Scientific title
Evaluation in a randomised controlled trial, of the efficacy and cost efficacy of an intervention (Conquer Fear) based on the Common Sense Model, S-REF and Relational Frame Theory, in reducing the impact of fear of cancer recurrence (FCR) in disease-free breast, colorectal and melanoma cancer survivors with clinical levels of FCR, compared to a relaxation training comparison intervention.
Secondary ID [1] 280069 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Conquer Fear
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of cancer recurrence 285978 0
Cancer-specific distress 286162 0
Quality of life 286163 0
Condition category
Condition code
Cancer 286168 286168 0 0
Breast
Cancer 286356 286356 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Mental Health 286357 286357 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring ; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviours; d) educate about follow-up care and empirically-supported behavioural change (e.g. weight loss, exercise etc) to reduce the risk of cancer recurrence; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting.
The intervention is delivered in 5 x 60-90 minute, individual face-to-face sessions by a trained psychologist or psychiatrist. Participants attend one session per fortnight over a period of 10 weeks. An individual approach is required with this group of highly anxious people to ensure effective skill-based training. In our cross-sectional study amongst young women with breast cancer higher FCR was significantly associated with current use of support groups in multivariate analysis. As the direction of the causality between FCR and support group use remains unclear, we believe it is most prudent to demonstrate proof of concept in an individually delivered intervention prior to testing the intervention in a group setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition.
Intervention code [1] 284391 0
Rehabilitation
Intervention code [2] 284513 0
Behaviour
Comparator / control treatment
Participants randomised to the comparison treatment will receive a 5-session manualized relaxation training program, adapted from an existing program for cancer patients. The relaxation training will be delivered in individual face-to-face sessions of 60-90 minutes in duration by a trained psychologist or psychiatrist. Participants attend one session per fortnight over a period of 10 weeks. Participants receive training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques, with regular homework exercises and a CD for practice outside sessions.
Control group
Active

Outcomes
Primary outcome [1] 286636 0
Fear of Cancer Recurrence will be assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI), the most comprehensive multi-dimensional scale of FCR available, and suitable for patients with mixed cancer diagnoses. The primary outcome variables will be specified as the (i) total FCRI score, and (ii) Severity Subscale of the FCRI.
Timepoint [1] 286636 0
At completion of treatment and 3 and 6 months later
Secondary outcome [1] 296338 0
Cancer-specific distress will be assessed with the 15 item Impact of Event Scale (IES) with two subscales: intrusion and avoidance.
Timepoint [1] 296338 0
At completion of treatment and 3 and 6 months later
Secondary outcome [2] 296339 0
Quality of Life (QoL) will be assessed with the AQoL8D, which is a health-related QOL instrument specifically developed for use in people with mental health problems. It is sensitive to change after psychosocial interventions since it includes domains such as depression/anxiety, social function, self esteem. The AQoL8D also allows the calculation of quality-adjusted-life years (QALYs) to be determined (through the health state utility scoring algorithm).
Timepoint [2] 296339 0
At completion of treatment and 3 and 6 months later
Secondary outcome [3] 296340 0
Economic outcomes, including service use, out of pocket patient and carer costs, and cost of the intervention will be estimated using two methods: 1) Self-report questions regarding use of resources; 2) Research team and provider records relating to delivery of the intervention.
Timepoint [3] 296340 0
At study completion

Eligibility
Key inclusion criteria
Eligible patients will have a confirmed past diagnosis of Stage 0-III breast cancer, Dukes stage A-C (corresponding to TNM staging I – IIB and IIIA) colorectal cancer, or stage IA – IIB melanoma. Additional eligibility criteria include being treated with curative intent; completed all hospital-based adjuvant treatments at least 2 months prior to and not more than 5 years prior to study entry; disease free; a score in the clinical range (13 or more) on the Severity Subscale of the Fear of Cancer Recurrence Inventory (FCRI), and able to read and write English and give informed consent.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current severe major depression, active psychotic illness or other psychiatric/cognitive condition which would impair the ability to give informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The proposed study is a randomised controlled trial, with patients randomly allocated to receive either the conquer fear intervention to reduce the impact of fear of cancer recurrence or relaxation training. Randomization will be performed by a statistician blinded to the identity of participants and therapists, using computer-generated random numbers, and patients will be allocated to the intervention arm or comparison group. The treatment team (other than psychologist) will be blinded to treatment allocation.
Participating sites will identify and write to all potentially eligible cancer survivors informing them of the study and inviting them to indicate interest and permission for the research team to contact them. The study team will contact interested patients to screen them for eligibility, obtain verbal consent, and mail the baseline assessment. All participants will provide written informed consent. Sites will be reimbursed for the psychologists time spent delivering the study interventions. Once recruited, patients will be assigned to a therapist (randomly, if more than one psychologist at their treatment centre is participating) and commence Conquer Fear or relaxation training sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used to generate the sequence in which subjects are randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The proposed study is a randomised controlled trial, with randomisation at the patient level.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
19/02/2013
Date of last participant enrolment
Anticipated
31/01/2016
Actual
31/01/2016
Date of last data collection
Anticipated
Actual
8/11/2016
Sample size
Target
246
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 284820 0
Government body
Name [1] 284820 0
Cancer Australia
Country [1] 284820 0
Australia
Funding source category [2] 284821 0
Charities/Societies/Foundations
Name [2] 284821 0
Beyondblue
Country [2] 284821 0
Australia
Funding source category [3] 284822 0
Charities/Societies/Foundations
Name [3] 284822 0
National Breast Cancer Foundation
Country [3] 284822 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Research Office, Jane Foss Russell Building (G02), University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 283702 0
Other Collaborative groups
Name [1] 283702 0
Psycho-Oncology Co-operative Research Group (PoCoG)
Address [1] 283702 0
PoCoG, Transient Building (F12), University of Sydney NSW 2006
Country [1] 283702 0
Australia
Other collaborator category [1] 260589 0
Individual
Name [1] 260589 0
Dr Belinda Thewes
Address [1] 260589 0
Centre for Medical Psychology and Evidence-based Decision Making, Transient Building (F12) University of Sydney NSW 2006
Country [1] 260589 0
Australia
Other collaborator category [2] 260590 0
Individual
Name [2] 260590 0
A/Prof Jane Turner
Address [2] 260590 0
Department of Psychiatry, University of Queensland, Brisbane St Lucia, QLD 4072
Country [2] 260590 0
Australia
Other collaborator category [3] 260591 0
Individual
Name [3] 260591 0
Dr Jemma Gilchrist
Address [3] 260591 0
Psycho-Oncology Department, Westmead Cancer Care Centre, Hawksbury Road Westmead NSW 2145
Country [3] 260591 0
Australia
Other collaborator category [4] 260592 0
Individual
Name [4] 260592 0
Prof Afaf Girgis
Address [4] 260592 0
Translational Cancer Research Unit, Ingham Institute for Applied Medical Research, Locked Mail Bag 7017, Liverpool BC NSW 1871
Country [4] 260592 0
Australia
Other collaborator category [5] 260593 0
Individual
Name [5] 260593 0
Prof Louise Sharpe
Address [5] 260593 0
School of Psychology, Brennan McCallum Building (A18) University of Sydney NSW 2006
Country [5] 260593 0
Australia
Other collaborator category [6] 260594 0
Individual
Name [6] 260594 0
Dr Melanie Bell
Address [6] 260594 0
Psycho-Oncology Co-operative Research Group, Transient Building (F12) University of Sydney NSW 2006
Country [6] 260594 0
Australia
Other collaborator category [7] 260595 0
Individual
Name [7] 260595 0
Aprof Jane Beith
Address [7] 260595 0
Dept of Medical Oncology, Royal Prince Alfted Hospital, Missenden Road Camperdown NSW 2050
Country [7] 260595 0
Australia
Other collaborator category [8] 260596 0
Individual
Name [8] 260596 0
Dr Cathy Mihalopoulos
Address [8] 260596 0
School of Health and Social Development
Level 5, Building J
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [8] 260596 0
Australia
Other collaborator category [9] 278070 0
Individual
Name [9] 278070 0
Ms Rachel Brebach
Address [9] 278070 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country [9] 278070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286810 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 286810 0
Ethics committee country [1] 286810 0
Australia
Date submitted for ethics approval [1] 286810 0
28/04/2012
Approval date [1] 286810 0
27/08/2012
Ethics approval number [1] 286810 0
Ethics committee name [2] 291420 0
South Eastern Sydney Local Health District HREC
Ethics committee address [2] 291420 0
Ethics committee country [2] 291420 0
Australia
Date submitted for ethics approval [2] 291420 0
13/12/2013
Approval date [2] 291420 0
13/12/2013
Ethics approval number [2] 291420 0
HREC/13/POWH/731

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33861 0
Prof Phyllis Butow
Address 33861 0
PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006
Country 33861 0
Australia
Phone 33861 0
+61 2 9351 2859
Fax 33861 0
Email 33861 0
[email protected]
Contact person for public queries
Name 17108 0
Ms Stephanie Tesson
Address 17108 0
PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006
Country 17108 0
Australia
Phone 17108 0
+61 2 9351 2518
Fax 17108 0
+61 2 90365292
Email 17108 0
[email protected]
Contact person for scientific queries
Name 8036 0
Ms Stephanie Tesson
Address 8036 0
PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006
Country 8036 0
Australia
Phone 8036 0
+61 2 9351 2518
Fax 8036 0
+61 2 90365292
Email 8036 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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