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BMC Cancer
Published in: BMC Cancer 1/2013

Open Access 01-12-2013 | Study protocol

Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence

Authors: Phyllis N Butow, Melanie L Bell, Allan B Smith, Joanna E Fardell, Belinda Thewes, Jane Turner, Jemma Gilchrist, Jane Beith, Afaf Girgis, Louise Sharpe, Sophy Shih, Cathrine Mihalopoulos, members of the Conquer Fear Authorship Group

Published in: BMC Cancer | Issue 1/2013

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Abstract

Background

Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR.

Methods/design

This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes.

Discussion

If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population.

Trial registration

Trial registration: ACTRN12612000404​820
Literature
1.
Australian Bureau of Statistics: National health survey: summary of results australia 2004–05. 2006, Canberra: Australian Bureau of Statistics
2.
Australian Institute of Health and Welfare: Cancer survival and prevalence in Australia; cancers diagnosed from 1982 to 2004. 2008, Canberra: AIHW
3.
Hewitt M, Greenfield S, Stovall E: From cancer patient to cancer survivor: lost in transition. 2006, Washington DC: Institute of Medicine (IOM)
4.
Vickberg SMJ: The concerns about recurrence scale (CARS): A systematic measure of women’s fears about the possibility of breast cancer recurrence. Ann Behav Med. 2003, 25 (1): 16-24. 10.1207/S15324796ABM2501_03.CrossRefPubMed
5.
Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A: Patients’ supportive care needs beyond the end of cancer treatment: A prospective, longitudinal survey. J Clin Oncol. 2009, 27 (36): 6172-6179. 10.1200/JCO.2009.22.5151.CrossRefPubMed
6.
Harrison SE, Watson EK, Ward AM, Khan NF, Turner D, Adams E, Forman D, Roche MF, Rose PW: Primary health and supportive care needs of long-term cancer survivors: A questionnaire survey. J Clin Oncol. 2011, 29 (15): 2091-2098. 10.1200/JCO.2010.32.5167.CrossRefPubMed
7.
Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P: The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer. 2000, 88 (1): 226-237. 10.1002/(SICI)1097-0142(20000101)88:1<226::AID-CNCR30>3.0.CO;2-P.CrossRefPubMed
8.
Simard S, Savard J: Screening and psychiatric comorbidity of clinical fear of cancer recurrence. 2008, 4th Canadian Breast Cancer Research Alliance Reasons for Hope Scientific Conference: Vancouver, Canada
9.
Thewes B, Butow P, Bell ML, Beith J, Stuart-Harris R, Grossi M, Capp A, Dalley D: Fear of cancer recurrence in young women with a history of early-stage breast cancer: a cross-sectional study of prevalence and association with health behaviours. Support Care Canc. 2012, 20 (11): 2651-2659. 10.1007/s00520-011-1371-x.CrossRef
10.
Thewes B, Boyes A, Girgis A: Abstracts of the IPOS 12th World Congress of Internation Psycho-Oncology Society (IPOS). 2010, Quebec City, Quebec, Canada: , 19: 235-Fear of cancer recurrence in the first year after diagnosis; Results of a registry based study Psycho-Oncology
11.
Humphris GM, Rogers S, McNally D, Lee-Jones C, Brown J, Vaughan D: Fear of recurrence and possible cases of anxiety and depression in orofacial cancer patients. Int J Oral Maxillofac Surg. 2003, 32 (5): 486-491. 10.1016/j.jpsychores.2008.03.014.CrossRefPubMed
12.
LLewellyn C, Weinman J, McGurk M, Humphris GM: Can we predict which head and neck cancer survivors develop fears of cancer recurrence?. J Psychosom Res. 2008, 65: 525-532. 10.1002/pon.1340.CrossRefPubMed
13.
van den Beuken-van Everdingen MHJ, Peters ML, de Rijke JM, Schouten HC, van Kleef M, Patijn J: Concerns of former breast cancer patients about disease recurrence: a validation and prevalence study. Psychooncology. 2008, 17 (11): 1137-1145. 10.1002/pon.1146.CrossRefPubMed
14.
Kornblith AB, Powell M, Regan MM, Bennett S, Krasner C, Moy B, Younger J, Goodman A, Berkowitz R, Winer E: Long-term psychosocial adjustment of older vs younger survivors of breast and endometrial cancer. Psychooncology. 2007, 16 (10): 895-903.CrossRefPubMed
15.
Ghazali N, Cadwallader E, Lowe D, Humphris G, Ozakinci G, Rogers SN: Fear of recurrence among head and neck cancer survivors: Longitudinal trends. Psychooncology. 2012, 10.1002/pon.3114.
16.
Crist JV, Grunfeld EA: Factors reported to influence fear of recurrence in cancer patients: A systematic review. Psychooncology. In Press
17.
Koch L, Jansen L, Brenner H, Arndt V: Fear of recurrence and disease progression in long-term (> 5 years) cancer survivors-a systematic review of quantitative studies. Psychooncology. 2012, 10.1002/pon.3022. In Press
18.
Skaali T, Fossa SD, Bremnes R, Dahl O, Klepp O, Wist E, Dahl AA: Fear of recurrence in long-term testicular cancer survivors. Psychooncology. 2007, 16 (9): P1-P172. 10.1002/pon.1346.
19.
Hodges L, Humphris G: Fear of recurrence and psychological distress in head and neck cancer patients and their carers. Psychooncology. 2009, 18 (8): 841-848. 10.1097/01.ju.0000091993.73842.9b.CrossRefPubMed
20.
Mehta SS, Lubeck DP, Pasta DJ, Litwin MS: Fear of cancer recurrence in patients undergoing definitive treatment for prostate cancer: results from CaPSURE. J Urol. 2003, 170 (5): 1931-1933. 10.1002/pon.1074.CrossRefPubMed
21.
Mellon S, Kershaw TS, Northouse LL, Freeman-Gibb L: A family-based model to predict fear of recurrence for cancer survivors and their caregivers. Psychooncology. 2007, 16 (3): 214-223.CrossRefPubMed
22.
Thewes B, Bell M, Smith A, Fardell J, Turner J, Butow P: Abstracts of the of IPOS 14th World Congress of Psycho-Oncology. 2012, 8: Conquer Fear: The development and pilot testing of a novel psychological treatment for fear of cancer recurrence, Asia-Pacific Journal of Clinical Oncology 207-10.1007/s00520-007-0296-x.
23.
Hart S, Latini D, Cowan J, Carroll P, CaPSURE Investigators: Fear of recurrence, treatment satisfaction, and quality of life after radical prostatectomy for prostate cancer. Supportive Cancer Care. 2008, 16: 161-169.CrossRef
24.
Glynne-Jones R, Chait I, Thomas F: When and how to discharge cancer curvivors in long term remission from follow-up: the effectiveness of a contract. Clin Oncol. 1997, 1: 25-29. 10.1056/NEJM199906033402206.CrossRef
25.
Maszczakiewicz E, Jolicoeur L, Lebel S, Lefevbre M, Bakker D: Fear of recurrence and its effects on patient satisfaction with follow-up after primary therapy for endometrial cancer. Abstracts of the Annual Scientific Meeting of the Canadian Association of Psychosocial Oncology. 2009, Vancouver, Canada:
26.
Burstein H, Gelber S, Guadognoli E, Weeks J: The use of alternative medicine by women with early-stage breast cancer. N Engl J Med. 1999, 340 (22): 1733-1739. 10.1111/j.1365-2354.2006.00722.x.CrossRefPubMed
27.
Montazeri A, Sajadian A, Ebrahimi M, Haghighat S, Harirchi I: Factors predicting the use of complementary and alternative therapies among cancer patients in Iran. Eur J Canc Care. 2007, 16 (2): 144-149. 10.1007/s10549-004-3779-1.CrossRef
28.
Rakovitch E, Pignol J, Chartier C, Ezer M, Verma S, Dranitsaris G, Clemons M: Complementary and alternative medicine use is associated with an increased perception of breast cancer risk and death. Breast Canc Res Treat. 2005, 90 (2): 139-148. 10.1348/135910708X283751.CrossRef
29.
Humphris GM, Ozackinci G: The AFTER intervention: A structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008, 13 (2): 223-230.CrossRefPubMed
30.
Easterling DV, Leventhal H: Contributions of concrete cognitionj to emotion: Neutral symptoms as elicitors of worry about cancer. J Appl Psychol. 1989, 74 (5): 787-796. 10.1002/pon.909.CrossRefPubMed
31.
Leventhal H, Nerenz DR, Steele DJ: Illness representations and coping with health threats. Handbook of psychology and health: Social psychological apsects of health. Edited by: Baum A, Taylor SE, Singer JE. 1984, Hillsdale: Lawrence Erlbaum Associates, 219-252.
32.
Mishel M, Germino B, Gil K, Belyea M, Laney I, Stewart J, Porter L, Clayton M: Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005, 14 (1): 962-978. 10.1007/s10198-010-0266-y.CrossRefPubMed
33.
Sabariego C, Brach M, Herschbach P, Berg P, Stucki G: Cost-effectiveness of cognitive-behavioral group therapy for dysfunctional fear of progression in cancer patients. Eur J Health Econ. 2011, 12 (5): 489-497. 10.1007/s00520-009-0696-1.CrossRefPubMed
34.
Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G: Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Canc. 2010, 18 (4): 471-479. 10.1080/08964289.2011.640364.CrossRef
35.
Dinkel A, Herschbach P, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G, Book K: Determinants of long-term response to group therapy for dysfunctional fear of progression in chronic diseases. Behav Med. 2012, 38 (1): 1-5. 10.1002/pon.1529.CrossRefPubMed
36.
Lengacher C, Jonhson-Mallard V, Post-White J, Moscosco M, Jacobsen P, Klein T, Widen R, Fitzgerald S, Shelton M, Barta M: Randomised controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009, 18 (12): 1261-1272.CrossRefPubMed
37.
Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher K, Pbert L, Linderking W, Santorelli SF: Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatr. 1992, 149 (7): 936-943. 10.1002/pon.1050.CrossRefPubMed
38.
Cameron LD, Booth R, Schlatter M, Ziginskas D, Harman J: Changes in emotion regulation and psychological adjustment following use of a group psychosocial support program for women recently diagnosed with breast cancer. Psychooncology. 2007, 16: 171-180. 10.1007/s00520-008-0444-y.CrossRefPubMed
39.
Simard S, Savard J: Fear of Cancer Recurrence Inventory: Development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Canc. 2009, 17 (3): 241-251.CrossRef
40.
Stein K, Kaw C, Spillers R: Abstracts of the IPOS 12th World Congress of Psycho-Oncology. 2012, 19: 17-Prevalence and Correlates of Fear of Cancer Recurrence among Cancer Survivors Psycho-Oncology
41.
Wells A: Metacognitive therapy: cognition applied to regulating cognition. Behav Cogn Psychother. 2008, 36 (Special Issue 06): 651-658.CrossRef
42.
Wells A, Matthews G: Modelling cognition in emotional disorder: The S-REF model. Behav Res Ther. 1996, 34 (11–12): 881-888. 10.1016/j.jclinepi.2008.03.008.CrossRefPubMed
43.
Hayes S, Strohsahl K, Wilson K: Acceptance and commitment therapy; an experiential approach to behaviour change. 2003, New York: Guildford Press
44.
Blackburn IM, James IA, Milne DL, Baker C, Standart S, Garland A, Reichelt FK: The revised cognitive therapy scale (CTS-R): Psychometric properties. Behav Cogn Psychother. 2001, 29 (4): 431-446.CrossRef
45.
Leeuw M, Goossens M, de Vet H, Vlaeyen J: The fidelity of treatment delivery can be assessed in treatment outcome studies: a successful illustration from behavioral medicine. J Clin Epidemiol. 2009, 62: 81-90.CrossRefPubMed
46.
Horowitz MJ, Wilner N, Alvarez W: Impact of event scale: a measure of subjective stress. Psychosom Med. 1979, 41: 209-218. 10.1348/014466505X29657.CrossRefPubMed
47.
Antony MM, Cox BJ, Enns MW, Bieling PJ, Swinson RP: Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychol Assess. 1998, 10 (2): 176-181.CrossRef
48.
Henry JD, Crawford JR: The short-form version of the depression anxiety stress scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005, 44 (2): 227-239. 10.1016/S0005-7967(03)00147-5.CrossRefPubMed
49.
Richardson J, Iezzi A, Khan M, Sinha K, Mihalopoulos C, Herrman H, Hawthorne G, Schweitzer I: Data used in the development of the AQoL-8D (PsyQoL) quality of life instrument. Research paper 40. 2009, Melbourne: Centre for Health Economics, Monash University
50.
Richardson J, Khan M, Iezzi A: Preliminary results for the validation of the assessment of quality of life AQoL-8D instrument. Research paper 47. 2010, Melbourne: Centre for Health Economics, Monash University
51.
Campbell HS, Sanson-Fisher R, Turner D, Hayward L, Wang XS, Taylor-Brown J: Psychometric properties of cancer survivors’ unmet needs survey. Support Care Canc. 2010, 19 (2): 221-230. 10.1016/j.paid.2008.04.005.CrossRef
52.
Wells A, Cartwright-Hatton S: A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004, 42 (4): 385-396.CrossRefPubMed
53.
Spada MM, Mohiyeddini C, Wells A: Measuring metacognitions associated with emotional distress: Factor structure and predictive validity of the metacognitions questionnaire 30. Personal Individ Differ. 2008, 45 (3): 238-242. 10.1080/10503300500352500.CrossRef
54.
Martin DJ, Garske JP, Davis MK: Relation of the therapeutic alliance with outcome and other variables: a meta-analytic review. J Consult Clin Psychol. 2000, 68 (3): 438-450. 10.1016/S0005-7916(00)00012-4.CrossRefPubMed
55.
Hatcher RL, Gillaspy JA: Development and validation of a revised short version of the working alliance inventory. Psychother Res. 2006, 16 (1): 12-25. 10.1200/JCO.2007.14.0822.CrossRef
56.
Smeets RJEM, Beelen S, Goossens MEJB, Schouten EGW, Knottnerus JA, Vlaeyen JWS: Treatment expectancy and credibility Are associated with the outcome of both physical and cognitive-behavioral treatment in chronic Low back pain. Clin J Pain. 2008, 24 (4): 305-315. 310.1097/AJP.1090b1013e318164aa318175.CrossRefPubMed
57.
Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatr. 2000, 31 (2): 73-86. 10.1016/j.jclinepi.2003.12.013.CrossRef
58.
Mandelblatt JS, Cullen J, Lawrence WF: Economic evaluation alongside a clinical trial of psycho-educational interventions to improve adjustment to survivorship among patients with breast cancer. J Clin Oncol. 2008, 26: 1684-1690.CrossRefPubMed
59.
Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ: Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004, 57 (8): 785-794.CrossRefPubMed
60.
Bell ML, McKenzie JE: Designing psycho-oncology randomised trials and cluster randomised trials: variance components and intra-cluster correlation of commonly used psychosocial measures. Psychooncology. 2012, 10.1002/pon.3205.
61.
Donner A, Klar N: Design and analysis of cluster randomization trials in health research. 2000, London, UK: Arnold Publishing
62.
Fitzmaurice GM, Laird NM, Ware JH: Applied longitudinal analysis. 2011, Hoboken NJ: Wiley, 2
63.
Baron RM, Kenny DA: The moderator-mediator variable distinction in social psychological research. Conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986, 51 (6): 1173-1182.CrossRefPubMed
64.
Metadata
Title
Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence
Authors
Phyllis N Butow
Melanie L Bell
Allan B Smith
Joanna E Fardell
Belinda Thewes
Jane Turner
Jemma Gilchrist
Jane Beith
Afaf Girgis
Louise Sharpe
Sophy Shih
Cathrine Mihalopoulos
members of the Conquer Fear Authorship Group
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2013
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-13-201

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