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

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; Gyorgy B. Halmos

doi:https://doi.org/10.1186/s12885-016-2613-6

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

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, Gyorgy B. Halmos

Research output: Contribution to journal › Article › Academic › peer-review

14 Citations (Scopus)

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.

Original language	English
Article number	580
Pages (from-to)	1-10
Number of pages	10
Journal	BMC Cancer
Volume	16
DOIs	https://doi.org/10.1186/s12885-016-2613-6
Publication status	Published - 2 Aug 2016

Keywords

Exercise program
Head and neck cancer
Shoulder problems
Speech problems
Swallowing problems
Total laryngectomy

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Jansen, F., Cnossen, I. C., Eerenstein, S. E. J., Coupé, V. M. H., Witte, B. I., van Uden-Kraan, C. F., Doornaert, P., Braunius, W. W., de Bree, R., Hardillo, J. A. U., Honings, J., Halmos, G. B., Leemans, C. R., Verdonck-de Leeuw, I. M., & Halmos, G. B. (2016). 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. BMC Cancer, 16, 1-10. Article 580. https://doi.org/10.1186/s12885-016-2613-6

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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",

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.",

keywords = "Exercise program, Head and neck cancer, Shoulder problems, Speech problems, Swallowing problems, Total laryngectomy",

author = "Femke Jansen and Cnossen, {Ingrid C} and Eerenstein, {Simone E J} and Coup{\'e}, {Veerle M H} and Witte, {Birgit I.} and {van Uden-Kraan}, {Cornelia F.} and Patricia Doornaert and Braunius, {Weibel W} and {de Bree}, Remco and Hardillo, {Jos{\'e} A U} and Jimmie Honings and Halmos, {Gy{\"o}rgy B} and Leemans, {C Ren{\'e}} and {Verdonck-de Leeuw}, {Irma M} and Halmos, {Gyorgy B.}",

year = "2016",

month = aug,

day = "2",

doi = "https://doi.org/10.1186/s12885-016-2613-6",

language = "English",

volume = "16",

pages = "1--10",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central",

}

Jansen, F, Cnossen, IC, Eerenstein, SEJ , Coupé, VMH, Witte, BI, van Uden-Kraan, CF, Doornaert, P, Braunius, WW, de Bree, R, Hardillo, JAU, Honings, J, Halmos, GB, Leemans, CR , Verdonck-de Leeuw, IM & Halmos, GB 2016, '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', BMC Cancer, vol. 16, 580, pp. 1-10. https://doi.org/10.1186/s12885-016-2613-6

TY - JOUR

T1 - 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

AU - Jansen, Femke

AU - Cnossen, Ingrid C

AU - Eerenstein, Simone E J

AU - Coupé, Veerle M H

AU - Witte, Birgit I.

AU - van Uden-Kraan, Cornelia F.

AU - Doornaert, Patricia

AU - Braunius, Weibel W

AU - de Bree, Remco

AU - Hardillo, José A U

AU - Honings, Jimmie

AU - Halmos, György B

AU - Leemans, C René

AU - Verdonck-de Leeuw, Irma M

AU - Halmos, Gyorgy B.

PY - 2016/8/2

Y1 - 2016/8/2

N2 - 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.

AB - 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.

KW - Exercise program

KW - Head and neck cancer

KW - Shoulder problems

KW - Speech problems

KW - Swallowing problems

KW - Total laryngectomy

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U2 - https://doi.org/10.1186/s12885-016-2613-6

DO - https://doi.org/10.1186/s12885-016-2613-6

M3 - Article

C2 - 27484126

SN - 1471-2407

VL - 16

SP - 1

EP - 10

JO - BMC Cancer

JF - BMC Cancer

M1 - 580

ER -

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

Abstract

Keywords

UN SDGs

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