scholarly journals SIP SMART: A parallel group randomised feasibility trial of a tailored pre-treatment Swallowing Intervention Package compared with usual care for patients with head and neck cancer

2020 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor
Keyword(s):  
Head And Neck Cancer ◽  
Usual Care ◽  
Head And Neck ◽  
Neck Cancer ◽  
Feasibility Trial ◽  
Size Estimation ◽  
Intervention Package ◽  
Parallel Group ◽  
Pre Treatment

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425

scholarly journals SIP SMART: A parallel group randomised feasibility trial of a tailored pre-treatment swallowing Intervention package compared with usual care for patients with head and neck cancer

2020 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor
Keyword(s):  
Head And Neck Cancer ◽  
Usual Care ◽  
Head And Neck ◽  
Neck Cancer ◽  
Feasibility Trial ◽  
Size Estimation ◽  
Intervention Package ◽  
Parallel Group ◽  
Pre Treatment

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS.Trial Registration: ISRCTN40215425, registered retrospectively http://www.isrctn.com/ISRCTN40215425

scholarly journals SIP SMART: A parallel group randomised feasibility trial of a tailored pre-treatment Swallowing Intervention Package compared with usual care for patients with head and neck cancer

2019 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor
Keyword(s):  
Head And Neck Cancer ◽  
Usual Care ◽  
Head And Neck ◽  
Neck Cancer ◽  
Feasibility Trial ◽  
Size Estimation ◽  
Intervention Package ◽  
Parallel Group ◽  
Pre Treatment

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425

scholarly journals SIP SMART: A parallel group randomised feasibility trial of a tailored pre-treatment Swallowing Intervention Package compared with usual care for patients with head and neck cancer

2019 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor
Keyword(s):  
Head And Neck Cancer ◽  
Usual Care ◽  
Head And Neck ◽  
Neck Cancer ◽  
Feasibility Trial ◽  
Size Estimation ◽  
Intervention Package ◽  
Parallel Group ◽  
Pre Treatment

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425

Oral Integrity Related to Head and Neck Cancer Treatment

2012 ◽  
Vol 21 (1) ◽  
pp. 28-33
Author(s):  
Annette H. May ◽  
E. Danielle Hiner ◽  
Elizabeth Feldman
Keyword(s):  
Head And Neck Cancer ◽  
Side Effects ◽  
Cancer Treatment ◽  
Head And Neck ◽  
Neck Cancer ◽  
Chronic Complications ◽  
Treatment Assessment ◽  
Pre Treatment

Head and neck cancer treatment can result in devastating side effects that diminish quality of life, sometimes for a lifetime. The purpose of this article is to highlight the importance of oral integrity in minimizing side effects to optimize long-term function in patients treated for head and neck cancer. We will present the value of a comprehensive pre-treatment assessment. We will describe the oral complications associated with surgery, radiation, and chemotherapy and offer approaches in management of acute and chronic complications.

scholarly journals Drawing: A novel approach to understanding appearance change in people following treatment for head and neck cancer

2019 ◽  
Vol 7 ◽  
pp. 205031211882034
Author(s):  
Sam Harding ◽  
John Bradford
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Post Treatment ◽  
Quality Of Life Scale ◽  
Related Quality ◽  
Health Related ◽  
Pre Treatment

Objectives: Appearance is a factor within head and neck cancer health-related quality of life measures; however, the issue of self-perceived appearance has received scant attention. Self-portraiture may provide insight into the patient’s perspective, allowing people to provide viewpoints that are not easily accessible. This research investigates the methodology of drawing and responses from patient-completed questionnaires in a head and neck cancer population. Methods: A sample of 30 people at least 3 months post-treatment for head and neck cancer were recruited. Participants completed the Derriford Appearance Scale, University of Washington Quality of Life scale, and two drawings: (1) how they recall themselves pre-treatment and (2) how they see themselves post-treatment. They were asked to discuss the methodology and their experience of it. Results: Correlations with Derriford Appearance Scale, University of Washington Quality of Life scale, and size drawings failed to find relationships between these variables. Post-treatment drawings were significantly smaller than pre-treatment. Qualitative analysis of the drawings found differences between the images. Participants related how drawing gave an opportunity to voice concerns that questionnaires and clinic appointments did not. Conclusion: Drawing can elicit distinctly different information about a person following treatment for head and neck cancer than that provided by health-related quality of life measures. Further research would clarify if clinical opinion matches patients’ drawing.

scholarly journals Early Quality of Life Outcomes In Head And Neck Cancer Survivors With EORTC QLQ-C30 And EORTC QLQ-HN35 In An Asian Tertiary Center

2021 ◽  
Author(s):  
Nern Hoong Kao ◽  
Gopalakrishna Iyer ◽  
Alice Foong Sin Chua ◽  
Rahul Harshad Nagadia
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Cancer Survivors ◽  
Head And Neck ◽  
Neck Cancer ◽  
Reference Values ◽  
Eortc Qlq C30 ◽  
Pre Treatment ◽  
Eortc Qlq

Abstract Background The objective of the study was to evaluate the quality of life (QOL) of head and neck cancer survivors after treatment and to identify patients’ main concerns. The study also aims to establish pre-treatment reference values particularly for the Asian patient. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Head and Neck module (EORTC QLQ-HN35) were used for objective evaluation.Methods Patients planned for elective surgery for head and neck cancers were enrolled in the study. The questionnaires were completed at pre-treatment and at 6 months after surgery. Results were compared with previously published reference values. Results 140 patients completed both questionnaires. Locally advanced tumour and extent of surgery [tracheostomy (p<0.01), surgical flap (p<0.01)] were associated with lower global health scores. Adjuvant treatment was also a contributory factor (p<0.01). Dysphagia and social eating was a primary concern within our population. Conclusion Treatment of head and neck cancers is safe but there is poor QOL in the early post-treatment period especially with eating. Previously published data suggests improvement after a year.

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