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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

The ENHANCES study—Enhancing Head and Neck Cancer patients’ Experiences of Survivorship: study protocol for a randomized controlled trial

Authors: Jane Turner, Patsy Yates, Lizbeth Kenny, Louisa G Gordon, Bryan Burmeister, Damien Thomson, Brett Hughes, Alexandra L McCarthy, Chris Perry, Raymond J Chan, Alana Fraser, Helen Skerman, Martin Batstone, Kathryn Carswell

Published in: Trials | Issue 1/2014

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Abstract

Background

Few cancers pose greater challenges than head and neck (H&N) cancer. Residual effects following treatment include body image changes, pain, fatigue and difficulties with appetite, swallowing and speech. Depression is a common comorbidity. There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment. In this study, we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer.

Methods/Design

This is a preliminary study in which 120 patients will be recruited. A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan (HNCP) involving pre- and post-intervention assessments will be used. Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms: (1) usual care, (2) information in the form of a written resource or (3) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support. The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP, based on principles of chronic disease self-management. Participants will be assessed at baseline, 3 and 6 months. The primary outcome measure is quality of life. The secondary outcome measures include mood, self-efficacy and health-care utilisation. The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses, managers and administrators. Interviews with patients who received the HNCP will explore their perceptions of the HNCP, including factors that assisted them in achieving behavioural change.

Discussion

In this study, we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment. Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and, if successful, will be a model of care that can be implemented for diverse patient populations.

Trial registration

ACTRN12613000542​796 (registered on 15 May 2013)
Appendix
Available only for authorised users
Literature
1.
Jemal A, Simard EP, Dorell C, Noone AM, Markowitz LE, Kohler B, Eheman C, Saraiya M, Bandi P, Saslow D, Cronin KA, Watson M, Schiffman M, Henley SJ, Schymura MJ, Anderson RN, Yankey D, Edwards BK: Annual Report to the Nation on the status of cancer, 1975–2009, featuring the burden and trends in human papillomavirus (HPV)–associated cancer and HPV vaccination coverage levels. J Natl Cancer Inst. 2013, 105: 175-201. 10.1093/jnci/djs491.CrossRefPubMedPubMedCentral
2.
Boyes A, Hodgkinson K, Aldridge L, Turner J: Issues for cancer survivors in Australia. Cancer Forum. 2009, 33: 164-167.
3.
Foley KL, Farmer DF, Petronis VM, Smith RG, McGraw S, Smith K, Carver CS, Avis N: A qualitative exploration of the cancer experience among long-term survivors: comparison by cancer type, ethnicity, gender and age. Psychooncology. 2006, 15: 248-258. 10.1002/pon.942.CrossRefPubMed
4.
From Cancer Patient to Cancer Survivor: Lost in Transition. Edited by: Hewitt M, Greenfield W, Stovall E. 2005, Washington, DC: The National Academies Press
5.
Fingeret MC, Yuan Y, Urbauer D, Weston J, Nipomnick S, Weber R: The nature and extent of body image concerns among surgically treated patients with head and neck cancer. Psychooncology. 2012, 21: 836-844. 10.1002/pon.1990.CrossRefPubMed
6.
Givens DJ, Karnell LH, Gupta AK, Clamon GH, Pagedar NA, Chang KE, Van Daele DJ, Funk GF: Adverse events associated with concurrent chemoradiation therapy in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2009, 135: 1209-1217. 10.1001/archoto.2009.174.CrossRefPubMed
7.
van Wilgen CP, Dijkstra PU, van der Laan BFAM, Plukker JT, Roodenburg JLN: Shoulder and neck morbidity in quality of life after surgery for head and neck cancer. Head Neck. 2004, 26: 839-844. 10.1002/hed.20052.CrossRefPubMed
8.
So WKW, Chan RJ, Chan DNS, Hughes BGM, Chair SY, Choi KC, Chan CWH: Quality-of-life among head and neck cancer survivors at one year after treatment—a systematic review. Eur J Cancer. 2012, 48: 2391-2408. 10.1016/j.ejca.2012.04.005.CrossRefPubMed
9.
Alicikus ZA, Akman F, Ataman OU, Dag N, Orcin E, Bakis B, Kinay M: Importance of patient, tumour and treatment related factors on quality of life in head and neck cancer patients after definitive treatment. Eur Arch Otorhinolaryngol. 2009, 266: 1461-1468. 10.1007/s00405-008-0889-0.CrossRefPubMed
10.
Carlson LE, Waller A, Groff SL, Giese-Davis J, Bultz B: What goes up does not always come down: patterns of distress, physical and psychosocial morbidity in people with cancer over a one year period. Psychooncology. 2013, 22: 168-176. 10.1002/pon.2068.CrossRefPubMed
11.
Boyes AW, Girgis A, Zucca AC, Lecathelinais C: Anxiety and depression among long-term survivors of cancer in Australia: results of a population-based survey. Med J Aust. 2009, 190 (7 Suppl): S94-S98.PubMed
12.
Chauker DA, Walvekar RR, Das AK, Deshpande MS, Pai PS, Chaturvedi P, Kakade A, D’Cruz AK: Quality of life in head and neck cancer survivors: a cross-sectional survey. Am J Otolaryngol. 2009, 30: 176-180. 10.1016/j.amjoto.2008.05.001.CrossRef
13.
Zabora J, BrintzenmhofeSzoc K, Curbow B, Hooker C, Piantadosi S: The prevalence of psychological distress by cancer site. Psychooncology. 2001, 10: 19-28. 10.1002/1099-1611(200101/02)10:1<19::AID-PON501>3.0.CO;2-6.CrossRefPubMed
14.
Sturgis EM, Wei O, Spitz MR: Descriptive epidemiology and risk factors for head and neck cancer. Semin Oncol. 2004, 31: 726-733. 10.1053/j.seminoncol.2004.09.013.CrossRefPubMed
15.
Kugaya A, Akechi T, Okamura H, Mikami I, Uchitomi Y: Correlates of depressed mood in ambulatory head and neck cancer patients. Psychooncology. 1999, 8: 494-499. 10.1002/(SICI)1099-1611(199911/12)8:6<494::AID-PON403>3.0.CO;2-M.CrossRefPubMed
16.
Lebel S, Castonguay M, Mackness G, Irish J, Bezjak A, Devins GM: The psychosocial impact of stigma in people with head and neck or lung cancer. Psychooncology. 2013, 22: 140-152. 10.1002/pon.2063.CrossRefPubMed
17.
18.
Sandfort JR, Pleasant A: Knowledge, attitudes, and informational behaviors of college students in regard to the human papillomavirus. J Am Coll Health. 2009, 58: 141-149. 10.1080/07448480903221368.CrossRefPubMed
19.
Kwan TTC, Tam K, Lee PWH, Lo SST, Chan KKL, Ngan HYS: De-stigmatising human papillomavirus in the context of cervical cancer: a randomised controlled trial. Psychooncology. 2010, 19: 1329-1339. 10.1002/pon.1706.CrossRefPubMed
20.
Luckett T, Britton B, Clover K, Rankin NM: Evidence for interventions to improve psychological outcomes in people with head and neck cancer: a systematic review of the literature. Support Care Cancer. 2011, 19: 871-881. 10.1007/s00520-011-1119-7.CrossRefPubMed
21.
Katz MR, Irish JC, Devins GM: Development and pilot testing of a psychoeducational intervention for oral cancer patients. Psychooncology. 2004, 13: 642-653. 10.1002/pon.767.CrossRefPubMed
22.
Semple CJ, Dunwoody L, Kernohan WG, McCaughan E: Development and evaluation of a problem-focused psychosocial intervention for patients with head and neck cancer. Support Care Cancer. 2009, 17: 379-388. 10.1007/s00520-008-0480-7.CrossRefPubMed
23.
Semple CJ, Dunwoody L, Kernohan WG, McCaughan E, Sullivan K: Changes and challenges to patients’ lifestyle patterns following treatment for head and neck cancer. J Adv Nurs. 2008, 63: 85-93. 10.1111/j.1365-2648.2008.04698.x.CrossRefPubMed
24.
25.
26.
Yates P, McCarthy A, Anderson D, Salkield G, Skerman H, Walpole E, Aguero C, Mile E: Development, implementation and evaluation of a cancer survivor self-management care plan [abstract 312]. Asia Pac J Clin Oncol. 2011, 7 (Suppl s4): 149-150.
27.
Girgis A, Butow P: Cancer survivorship: research priorities at the national and international levels. Cancer Forum. 2009, 33 (3): 3-
28.
Wagner EH, Austin BT, Von Korff M: Improving outcomes in chronic illness. Manag Care Q. 1996, 4: 12-25.PubMed
29.
Gao WJ, Yuan CR: Self-management programme for cancer patients: a literature review. Int Nurs Rev. 2011, 58: 288-295. 10.1111/j.1466-7657.2011.00907.x.CrossRefPubMed
30.
Bandura A: Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977, 84: 191-215.CrossRefPubMed
31.
Wagner EH, Austin BT, Von Korff M: Organizing care for patients with chronic illness. Milbank Q. 1996, 74: 511-544. 10.2307/3350391.CrossRefPubMed
32.
Ringash J, Bezjak A, O’Sullivan B, Redelmeier DA: Interpreting differences in quality of life: the FACT-H&N in laryngeal cancer patients. Qual Life Res. 2004, 13: 725-733.CrossRefPubMed
33.
List MA, D’Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E: The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy–Head and Neck (FACT-H&N) scale: a study of utility and validity. Cancer. 1996, 77: 2294-2301. 10.1002/(SICI)1097-0142(19960601)77:11<2294::AID-CNCR17>3.0.CO;2-S.CrossRefPubMed
34.
Hertzog MA: Considerations in determining sample size for pilot studies. Res Nurs Health. 2008, 31: 180-191. 10.1002/nur.20247.CrossRefPubMed
35.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T, CONSORT Group: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001, 134: 663-694. 10.7326/0003-4819-134-8-200104170-00012.CrossRefPubMed
36.
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Slieverman M, Yellen SB, Winicour P, Brannon J: The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol. 1993, 11: 570-579.PubMed
37.
D’Antonio LL, Zimmerman GJ, Cella DF, Long SA: Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996, 122: 482-487. 10.1001/archotol.1996.01890170018005.CrossRefPubMed
38.
Merluzzi TV, Nairn RC, Hegde K, Martinez Sanchez MA, Dunn L: Self-efficacy for coping with cancer: revision of the Cancer Behaviour Inventory (version 2.0). Psychooncology. 2001, 10: 206-217. 10.1002/pon.511.CrossRefPubMedPubMedCentral
39.
Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983, 67: 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
40.
Group EQ: EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16: 199-208.CrossRef
41.
Viney R, Norman R, King MT, Cronin P, Street DJ, Knox S, Ratcliffe J: Time trade-off derived EQ-5D weights for Australia. Value Health. 2011, 14: 928-936. 10.1016/j.jval.2011.04.009.CrossRefPubMed
42.
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. 2005, Oxford: Oxford University Press, 3
43.
Efron B, Tibshirani RJ: An Introduction to the Bootstrap. 1993, Boca Raton, FL: Chapman & HallCrossRef
44.
McArdle JMC, George WD, McArdle CS, Smith DC, Moodie AR, Hughson AVM, Murray GD: Psychological support for patients undergoing breast cancer surgery: a randomised study. BMJ. 1996, 312: 813-816. 10.1136/bmj.312.7034.813.CrossRefPubMedPubMedCentral
45.
Barney LJ, Griffiths KM, Christensen H, Jorm AF: Exploring the nature of stigmatising beliefs about depression and help-seeking: implications for reducing stigma. BMC Public Health. 2009, 9: 61-10.1186/1471-2458-9-61.CrossRefPubMedPubMedCentral
46.
Schomerus G, Matschinger H, Angermeyer MC: The stigma of psychiatric treatment and help-seeking intentions for depression. Eur Arch Psychiatry Clin Neurosci. 2009, 259: 298-306. 10.1007/s00406-009-0870-y.CrossRefPubMed
47.
Simon GE, Fleck M, Lucas R, Bushnell DM, LIDO Group: Prevalence and predictors of depression treatment in an international primary care study. Am J Psychiatry. 2004, 161: 1626-1634. 10.1176/appi.ajp.161.9.1626.CrossRefPubMed
48.
Carlson LE, Bultz BD: Efficacy and medical cost offset of psychosocial interventions in cancer care: making the case for economic analyses. Psychooncology. 2004, 13: 837-856. 10.1002/pon.832.CrossRefPubMed
Metadata
Title
The ENHANCES study—Enhancing Head and Neck Cancer patients’ Experiences of Survivorship: study protocol for a randomized controlled trial
Authors
Jane Turner
Patsy Yates
Lizbeth Kenny
Louisa G Gordon
Bryan Burmeister
Damien Thomson
Brett Hughes
Alexandra L McCarthy
Chris Perry
Raymond J Chan
Alana Fraser
Helen Skerman
Martin Batstone
Kathryn Carswell
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-191

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