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Published in: BMC Cancer 1/2016

Open Access 01-12-2016 | Study protocol

Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial

Authors: Femke Jansen, Ingrid C. Cnossen, Simone E. J. Eerenstein, Veerle M. H. Coupé, Birgit I. Witte, Cornelia F. van Uden-Kraan, Patricia Doornaert, Weibel W. Braunius, Remco De Bree, José A. U. Hardillo, Jimmie Honings, György B. Halmos, C. René Leemans, Irma M. Verdonck-de Leeuw

Published in: BMC Cancer | Issue 1/2016

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Abstract

Background

Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy.

Methods/design

Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.

Discussion

This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.

Trial registration

NTR5255 Protocol version 4 date September 2015.
Literature
1.
Dutch Cancer Registry, maintained by IKNL. Accessed July 2015. 2014.
2.
Timmermans AJ, Krap M, Hilgers FJM, van den Brekel MWM. Speech revalidation after total laryngectomy. Ned Tijdschr Tandheelkd. 2012;119:357–61.CrossRefPubMed
3.
Szuecs M, Kuhnt T, Punke C, Witt G, Klautke G, Kramp B, et al. Subjective voice quality, communicative ability and swallowing after definitive radio(chemo)therapy, laryngectomy plus radio(chemo)therapy, or organ conservation surgery plus radio(chemo)therapy for laryngeal and hypopharyngeal cancer. J Radiat Res. 2015;56:159–68.CrossRefPubMed
4.
Maclean J, Cotton S, Perry A. Post-Laryngectomy: It’s Hard to Swallow. Dysphagia. 2009;24:172–9.CrossRefPubMed
5.
Burnip E, Owen SJ, Barker S, Patterson JM. Swallowing outcomes following surgical and non-surgical treatment for advanced laryngeal cancer. J Laryngol Otol. 2013;127:1116–21.CrossRefPubMed
6.
Moukarbel RV, Fung K, Franklin JH, Leung A, Rastogi R, Anderson CM, et al. Neck and Shoulder Disability Following Reconstruction With the Pectoralis Major Pedicled Flap. Laryngoscope. 2010;120:1129–34.PubMed
7.
Perry A, Casey E, Cotton S. Quality of life after total laryngectomy: functioning, psychological well-being and self-efficacy. Int J Lang Commun Disord. 2015;50:467–75.CrossRefPubMed
8.
Rinkel RNPM, Verdonck-de Leeuw IM, van den Brakel N, de Bree R, Eerenstein SEJ, Aaronson N, et al. Patient-reported symptom questionnaires in laryngeal cancer: Voice, speech and swallowing. Oral Oncol. 2014;50:759–64.CrossRefPubMed
9.
Singer S, Danker H, Guntinas-Lichius O, Oeken J, Pabst F, Schock J, et al. Quality of life before and after total laryngectomy: results of a multicenter prospective cohort study. Head Neck. 2014;36:359–68.CrossRefPubMed
10.
Ahlberg A, Engström T, Nikolaidis P, Gunnarsson K, Johansson H, Sharp L, et al. Early self-care rehabilitation of head and neck cancer patients. Acta Otolaryngol. 2011;131:552–61.CrossRefPubMedPubMedCentral
11.
Carnaby-Mann G, Crary MA, Schmalfuss I, Amdur R. “Pharyngocise”: Randomized Controlled Trial of Preventive Exercises to Maintain Muscle Structure and Swallowing Function During Head-and-Neck Chemoradiotherapy. Int J Radiat Oncol. 2012;83:210–9.CrossRef
12.
Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment Swallowing Exercises Improve Swallow Function After Chemoradiation. Laryngoscope. 2008;118:39–43.CrossRefPubMed
13.
Duarte VM, Chhetri DK, Liu YF, Erman AA, Wang MB. Swallow preservation exercises during chemoradiation therapy maintains swallow function. Otolaryngol Head Neck Surg. 2013;149:878–84.CrossRefPubMedPubMedCentral
14.
Hutcheson KA, Bhayani MK, Beadle BM, Gold KA, Shinn EH, Lai SY, et al. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013;139:1127–34.CrossRefPubMedPubMedCentral
15.
Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, et al. Prophylactic Swallowing Exercises in Patients With Head and Neck Cancer Undergoing Chemoradiation. A Randomized Trial. Arch Otolaryngol Head Neck Surg. 2012;138:376–82.CrossRefPubMed
16.
Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, et al. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006;116:883–6.CrossRefPubMed
17.
McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, et al. Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivors: a randomized controlled trial. Cancer. 2008;113:214–22.CrossRefPubMed
18.
McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, et al. Sustainability of Outcomes after a Randomized Crossover Trial of Resistance Exercise for Shoulder Dysfunction in Survivors of Head and Neck Cancer. Oncology. 2015;67:85–93.
19.
McNeely ML, Parliament M, Courneya KS, Seikaly H, Jha N, Scrimger R, et al. A pilot study of a randomized controlled trial to evaluate the effects of progressive resistance exercise training on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in head and neck cancer survivors. Head Neck. 2004;26:518–30.CrossRefPubMed
20.
Mortensen HR, Jensen K, Aksglaede K, Lambertsen K, Eriksen E, Grau C. Prophylactic Swallowing Exercises in Head and Neck Cancer Radiotherapy. Dysphagia. 2015;30:304–14.CrossRefPubMed
21.
Ohba S, Yokoyama J, Kojima M, Fujimaki M, Anzai T, Komatsu H, et al. Significant preservation of swallowing function in chemoradiotherapy for advanced head and neck cancer by prophylactic swallowing exercise. Head Neck. 2015. doi:10.​1002/​hed.​23913.
22.
Shinn EH, Basen-Engquist K, Baum G, Steen S, Bauman RF, Morrison W, et al. Adherence to preventive exercises and self-reported swallowing outcomes in post-radiation head and neck cancer patients. Head Neck. 2013;35:1707–12.CrossRefPubMedPubMedCentral
23.
Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011;187:39–44.CrossRefPubMed
24.
van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CRN, Hilgers FJM. A Randomized Preventive Rehabilitation Trial in Advanced Head and Neck Cancer Patients Treated With Chemotherapy: Feasibility, Compliance, and Short-term Effects. Dysphagia. 2011;26:155–70.CrossRefPubMed
25.
van der Molen L, van Rossum MA, Rasch CRN, Smeele LE, Hilgers FJM. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014;271:1257–70.CrossRefPubMed
26.
Virani A, Kunduk M, Fink D, McWhorter A. Effects of 2 different swallowing exercise regimens during organ-preservation therapies for head and neck cancers on swallowing function. Head Neck. 2015;37:162–70.CrossRefPubMed
27.
McGarvey AC, Hoffman GR, Osmotherly PG, Chiarelli PE. Maximizing shoulder function after accesory nerve injury and neck dissection surgery: A multicenter randomized controlled trial. Head Neck. 2015;37:1022–31.CrossRefPubMed
28.
Cnossen IC, van Uden-Kraan CF, Rinkel RNPM, Aalders IJ, de Goede CJT, de Bree R, et al. Multimodal guided self-help exercise program to prevent speech, swallowing, and shoulder problems among head and neck cancer patients: a feasibility study. J Med Internet Res. 2014;16:e74.CrossRefPubMedPubMedCentral
29.
Leykin Y, Thekdi SM, Shumay DM, Munoz RF, Riba M, Dunn LB. Internet Interventions for Improving Psychological Well-Being in Psycho-Oncology: Review and Recommendations. Psychooncology. 2012;21:1016–25.CrossRefPubMed
30.
Cnossen IC, van Uden-Kraan CF, Eerenstein SEJ, Rinkel RNPM, Aalders IJ, van den Berg K, et al. A participatory design approach to develop a web-based self-care program supporting early rehabilitation among patients after total laryngectomy. Folia Phoniatr Logop. 2015;67(4):193–201.CrossRefPubMed
31.
32.
33.
Rinkel RN, Verdonck-de Leeuw IM, Langendijk JA, van Reij EJ, Aaronson NK, Leemans CR. The psychometric and clinical validity of the SWAL-QOL questionnaire in evaluating swallowing problems experienced by patients with oral and oropharyngeal cancer. Oral Oncol. 2009;45:e67–71.CrossRefPubMed
34.
Rinkel RN, Verdonck-de Leeuw IM, van Reij EJ, Aaronson NK, Leemans CR. Speech Handicap Index in patients with oral and pharyngeal cancer: better understanding of patients’ complaints. Head Neck. 2008;30:868–74.CrossRefPubMed
35.
van der Windt DA, van der Heijden GJ, de Winter AF, Koes BW, Deville W, Bouter LM. The responsiveness of the Shoulder Disability Questionnaire. Ann Rheum Dis. 1998;57:82–7.CrossRefPubMedPubMedCentral
36.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRefPubMed
37.
Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, et al. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999;17:1008–19.PubMed
38.
Rademakers J, Nijman J, van der Hoek L, Heijmans M, Rijken M. Measuring patient activation in the Netherlands: translation and validation of the American short form Patient Activation Measure (PAM13). BMC Public Health. 2012;12:577.CrossRefPubMedPubMedCentral
39.
40.
Lamers LM, Stalmeier PFM, McDonnell J, Krabbe PFM, van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005;149:1574–8.PubMed
41.
Bouwmans C, Hakkaart-van Rooijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. [Guideline iMTA Medical Consumption Questionnaire]. 2013.
42.
Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. [Guideline iMTA Productivity Costs Questionnaire]. 2013.
43.
Hakkaart-van Rooijen L, Tan SS, Bouwmans CAM. [Guideline for cost research. Methods and standard cost prices for economic evaluations in healthcare]. 2010;
44.
Kallogjeri D, Gaynor SM, Piccirillo ML, Jean RA, Spitznagel Jr EL, Piccirillo JF. Comparison of Comorbidity Collection Methods. J Am Coll Surg. 2014;219:245–55.CrossRefPubMedPubMedCentral
45.
Retèl VP, van der Molen L, Hilgers FJM, Rasch CRN, L’Ortye AAAMHJ, Steuten LMG, et al. A cost-effectiveness analysis of a preventive exercise program for patients with advanced head and neck cancer treated with concomitant chemo-radiotherapy. BMC Cancer. 2011;11:475.CrossRefPubMedPubMedCentral
46.
47.
Metadata
Title
Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial
Authors
Femke Jansen
Ingrid C. Cnossen
Simone E. J. Eerenstein
Veerle M. H. Coupé
Birgit I. Witte
Cornelia F. van Uden-Kraan
Patricia Doornaert
Weibel W. Braunius
Remco De Bree
José A. U. Hardillo
Jimmie Honings
György B. Halmos
C. René Leemans
Irma M. Verdonck-de Leeuw
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2016
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-016-2613-6

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