ANZCTR - Registration

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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]

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

Cancer-specific distress

Quality of life

Condition category

Condition code

Cancer

Breast

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Mental Health

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]

Rehabilitation

Intervention code [2]

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]

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]

At completion of treatment and 3 and 6 months later

Secondary outcome [1]

Cancer-specific distress will be assessed with the 15 item Impact of Event Scale (IES) with two subscales: intrusion and avoidance.

Timepoint [1]

At completion of treatment and 3 and 6 months later

Secondary outcome [2]

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]

At completion of treatment and 3 and 6 months later

Secondary outcome [3]

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]

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?

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]

Government body

Name [1]

Cancer Australia

Address [1]

Level 14, 300 Elizabeth Street, SURRY HILLS NSW 2010

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Beyondblue

Address [2]

PO Box 6100
Hawthorn West VIC 3122

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

National Breast Cancer Foundation

Address [3]

Level 9, 50 Pitt Street, SYDNEY NSW 2000

Country [3]

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]

Other Collaborative groups

Name [1]

Psycho-Oncology Co-operative Research Group (PoCoG)

Address [1]

PoCoG, Transient Building (F12), University of Sydney NSW 2006

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Belinda Thewes

Address [1]

Centre for Medical Psychology and Evidence-based Decision Making, Transient Building (F12) University of Sydney NSW 2006

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

A/Prof Jane Turner

Address [2]

Department of Psychiatry, University of Queensland, Brisbane St Lucia, QLD 4072

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Jemma Gilchrist

Address [3]

Psycho-Oncology Department, Westmead Cancer Care Centre, Hawksbury Road Westmead NSW 2145

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Prof Afaf Girgis

Address [4]

Translational Cancer Research Unit, Ingham Institute for Applied Medical Research, Locked Mail Bag 7017, Liverpool BC NSW 1871

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Prof Louise Sharpe

Address [5]

School of Psychology, Brennan McCallum Building (A18) University of Sydney NSW 2006

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr Melanie Bell

Address [6]

Psycho-Oncology Co-operative Research Group, Transient Building (F12) University of Sydney NSW 2006

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Aprof Jane Beith

Address [7]

Dept of Medical Oncology, Royal Prince Alfted Hospital, Missenden Road Camperdown NSW 2050

Country [7]

Australia

Other collaborator category [8]

Individual

Name [8]

Dr Cathy Mihalopoulos

Address [8]

School of Health and Social Development
Level 5, Building J
Deakin University
221 Burwood Highway
Burwood VIC 3125

Country [8]

Australia

Other collaborator category [9]

Individual

Name [9]

Ms Rachel Brebach

Address [9]

School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006

Country [9]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cancer Institute NSW Clinical Research Ethics Committee

Ethics committee address [1]

Cancer Institute NSW
Australian Technology Park
Level 9, 8 Central Avenue
Eveleigh NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2012

Approval date [1]

27/08/2012

Ethics approval number [1]

Ethics committee name [2]

South Eastern Sydney Local Health District HREC

Ethics committee address [2]

Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
Randwick NSW 2031

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

13/12/2013

Approval date [2]

13/12/2013

Ethics approval number [2]

HREC/13/POWH/731

Summary

Brief summary

Do you worry a lot about the possibility of cancer recurrence?
Does this worry affect your life?

Almost all cancer survivors worry from time to time about the possibility of their cancer returning. For some people these fears are frequent, very distressing and make it hard to enjoy life. 

If you suffer from frequent or severe worry about the possibility of your cancer coming back, and it is getting in the way of how you wish to lead your life, you may be interested to join a research study comparing two different psychological treatments to help people to better manage fear of cancer recurrence. Hospitals around Australia are conducting the study together with a team of researchers from the Psycho-Oncology Co-operative Research Group at the University of Sydney, led by Prof Phyllis Butow. 

Am I eligible to be involved in this study?
We are seeking people over the age of 18 years who: 
1) Have been diagnosed with stage 0-III breast cancer, stage I-IIIA colorectal cancer, or stage IA-IIB melanoma;
2) Have completed hospital-based treatments (surgery, chemotherapy, or radiotherapy) more than 2 months and less than 5 years ago; 
3) Have no medical evidence of active cancer; 
4) Can speak and read English well; 
5) Experience a high level of worry about their cancer coming back

What does this study involve?
If you decide to participate in the study, you will receive a psychological treatment focused on either the more physical (tension) aspects or the more mental (worry) aspects of fear of cancer recurrence. Which treatment you get, will be decided randomly (by chance). Both treatments will be provided free of charge and will involve attending five individual sessions with a psychologist or psychiatrist, each lasting 60-90 minutes, over a period of 10 weeks (one session per fortnight). You will also be asked to practice some of the techniques you learn during the sessions at home.

In addition to attending treatment sessions, you will be asked to complete a questionnaire to evaluate how well your treatment is working at four time-points: 1) before treatment; 2) immediately after you complete treatment; 3) 3 months after you complete treatment; and 4) 6 months after you complete treatment. You may also be invited to participate in a 30-minute phone interview about your experience and satisfaction with the treatment you received.

Where do I find more information?
If you are interested in being involved or to find out if you are eligible please contact the research co-ordinator (Stephanie Tesson) at the University of Sydney by phoning 02 9351 4518 or emailing conquer.fear@psych.usyd.edu.au

This study has been approved by the Human Research Ethics Committee South Eastern Sydney Local Health District (SESLHD)

Trial website

Trial related presentations / publications

Book Chapter
Butow P, Fardell J, Smith AB. Fear of cancer recurrence. In Holland J et al. (Eds.) Psycho-Oncology 3rd Edition (pp. 625-629). New York: Oxford University Press, 2015. 

Journal Articles
Costa, D., Smith, A., and Fardell, J. The sum of all fears: Conceptual challenges with
measuring fear of cancer recurrence. Supportive Care in Cancer 2016; 24:1-3. Impact Factor:
2.364.

Fear of cancer recurrence: An overview and Australian perspective. Butow P, Fardell, J, Smith, A. Cancer Forum 2015; 39(2): 95-100. H Index: 10.

Smith AB, Thewes B, Turner J, Gilchrist J, Fardell J, Sharpe L, Bell M, Girgis A, Grier M, Byrne D, Clutton S, Butow P. (2015) Pilot of a theoretically grounded psychologist-delivered intervention for fear of cancer recurrence (Conquer Fear). Psycho-Oncol, Published online 1 March 2015.

Fardell JE, Thewes B, Turner J, Gilchrist J, Sharpe L, Smith AB, Girgis A, Butow P. Fear of
cancer recurrence: A theoretical review and novel cognitive processing formulation. J Cancer Surviv. Published online 19/1/2016. DOI 10.1007/s11136-015-1088-2.

Butow P, Bell M, Smith A, Fardell J, Thewes B, Turner J, Gilchrist J, Beith J, Girgis A,
Sharpe L, Shih S, Mihalopoulos C, members of the Conquer Fear Authorship Group.
(2013) Conquer fear: protocol of a randomised controlled trial of a psychological
intervention to reduce fear of cancer recurrence. BMC Cancer, 13(1):201.

Conference Presentations
Butow, P. A randomised controlled trial (RCT) of a psychological intervention (Conquer
Fear) to reduce clinical levels of fear of cancer recurrence in breast, colorectal, and melanoma cancer survivors. Clinical Oncology Society of Australia 43rd Annual Scientific Meeting, Gold Coast, Australia, November 2016.

Turner, J. A randomised controlled trial (RCT) of a psychological intervention (Conquer
Fear) to reduce clinical levels of fear of cancer recurrence in breast, colorectal, and
melanoma cancer survivors. 18th International Psycho-Oncology Society World
Congress, Dublin, Ireland, October 2016.

Tesson, S. A randomised controlled trial of a psychological intervention to reduce fear
of cancer recurrence. Sydney Cancer Conference, Sydney, Australia, September 2016.

Sharpe, L. Treatment of chronic physical health problems using cognitive behaviour therapy. World Congress of Behavioural and Cognitive Therapies, Melbourne, Australia, June 2016.

Turner, J. Fear of cancer recurrence. European Society of Medical Oncology Asian
Meeting. Singapore, December 2015.

Smith AB, Thewes B, Turner J, Gilchrist J, Fardell J, Girgis A, Sharpe L, Beith J, Bell
M, Mihalopoulos C, Brebach R, Shih S, Butow P. Can you really conquer fear?
Development and evaluation of a novel approach to managing cancer survivors’ fear of
recurrence in a parallel randomised controlled trial. Victorian Psycho-Oncology
Research Conference, Melbourne, Australia, Oct 2015.

Smith AB, Fardell J, Thewes B, Coll J, Turner J, Gilchrist J, Girgis A, Sharpe L, Beith J,
Mihalopoulos C, Butow P. Screening for clinical levels of fear of cancer recurrence
using the Fear of Cancer Recurrence Inventory Severity Subscale: Lessons learnt from
the Conquer Fear study. Second International Fear of Cancer Recurrence Symposium,
Ottawa, Canada, Aug 2015.

Butow P, Turner J, Gilchrist J, Fardell J, Smith AB, Girgis A, Sharpe L, Beith J, Bell M,
Mihalopoulos C, Brebach R, Shih S, Thewes B, . Evaluation a theoretically grounded
psychologist-delivered intervention for fear of cancer recurrence (Conquer Fear): Pilot
results and RCT progress update. Second International Fear of Cancer Recurrence
Symposium, Ottawa, Canada, Aug 2015.

Turner J, Butow P, Thewes B, Gilchrist J, Beith J, Girgis A, Sharpe L, Bell M,
Mihalopoulos C, Shih S, Smith A, Fardell J. They say the odds are good, but I can’t
stop thinking about it: Responding to Fear of Cancer Recurrence. Asia-Pacific Journal 
of Clinical Oncology 2014; 10 (Suppl. 8):77-124.

Fardell, J.E. (2013) Psycho-oncology clinicians in research: the importance and
methodological considerations of psycho-oncology randomised control trials. Psycho
Oncology Co-operative Research Group Professional Day at the Clinical Oncology
Society of Australia (COSA), 40th Annual Scientific Meeting, Adelaide, Australia

Butow, P., Thewes, B., Turner, J., Gilchrist, J., Bell, M., Smith, A., Fardell, J., Beith, J.,
Girgis, A., Sharpe, L., Shih, S., Mihalopoulos, C., Fairclough, M., Francis, A. and Grier,
M. (2013). Conquer Fear a randomised trial evaluating psychological interventions to
reduce fear of cancer recurrence. Research Excellence in Cancer Care - The Inaugural
Research Symposium to Support the Diamond Standard of Cancer Care, Royal
Brisbane and Women’s Hospital, Australia.

Thewes, B., Bell, M., Smith, A., Fardell, J. E., Turner, J., Butow, P. and the PoCoG
FCR Working Group (2012). Conquer Fear: The development and pilot testing of a
novel psychological treatment for fear of cancer recurrence. . Paper presented at the
IPOS 14th World Congress and COSA's 39th Annual Scientific Meeting, Brisbane,
Australia.

Thewes, B., Bell, M., Smith, A., Fardell, J. E., Turner, J., Butow, P. and the PoCoG
FCR Working Group (2012). Conquer Fear: The development and pilot testing of a
novel psychological treatment for fear of cancer recurrence. Paper presented at the
Sydney Cancer Conference, Sydney, Australia.

Workshops
Butow P, Turner J, Sharpe L.  Fear of recurrence: a novel framework and therapy model. Workshop presented at International Psycho-Oncology Society World Congress, Washington, August 2015.

Butow P, Turner J, Sharpe L.  Fear of recurrence: a novel framework and therapy
model. Workshop presented at International Psycho-Oncology Society World
Congress, Washington, August 2015.

Butow P, Turner J. Fear of recurrence: a novel framework and therapy model. Workshop
presented at International Psycho-Oncology Society World Congress, Lisbon, October 2014.

Public notes

Contacts

Principal investigator

Name

Prof Phyllis Butow

Address

PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 2859

Fax

phyllis.butow@sydney.edu.au

Contact person for public queries

Name

Ms Stephanie Tesson

Address

PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 2518

Fax

+61 2 90365292

conquer.fear@psych.usyd.edu.au

Contact person for scientific queries

Name

Ms Stephanie Tesson

Address

PoCoG, Level 6 North
Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 2518

Fax

+61 2 90365292

conquer.fear@psych.usyd.edu.au

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No Supporting Document Provided

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