None listed
Conditions
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)
Interventions
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 del
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Exclusion criteria
Current severe major depression, active psychotic illness or other psychiatric/cognitive condition which would impair the ability to give informed consent.
Outcome results
None listed