SIP SMART: Swallowing Intervention package - Self Monitoring, Assessment & Rehabilitation Training

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Head and Neck Cancer; Cancer; Disease: Head and Neck

• Registration Number: ISRCTN40215425
• Lead Sponsor: niversity College London

Brief Summary

2016 protocol in https://bmjopen.bmj.com/content/7/3/e014167 2020 results in https://pubmed.ncbi.nlm.nih.gov/32349693/ (added 05/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-23
• Study Completion: 2017-08-30
• Last Update Posted: 15 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Qualitative Interviews:
1. Patients who have completed treatment for advanced head and neck cancer
2. A minimum of 3 months post treatment
3. Had input from a SLT as part of their cancer care
4. Able to provide informed consent and willing to be interviewed for 40 minutes
5. Proficiency in English satisfactory for interview/participation in intervention
6. Aged 18 and above

Preliminary testing : feasibility study
1. Patients with newly diagnosed stage III and stage IV head and neck cancer
2. Discussed at the UCLH head and neck MDT and planned for curative treatment via surgery and/or chemoradiotherapy or combinations thereof
3. Able to provide informed consent
4. Proficiency in English satisfactory to participate/engage in the intervention
5. Aged 18 and above

Exclusion Criteria

1. Patients who are mid treatment or those receiving palliation
2. Patients who have been treated solely by non standard treatment ie not surgery, radiotherapy, chemoradiotherapy or combinations thereof. Patients treated by chemotherapy, brachy therapy, photodynamic therapy alone will be ineligible.
3. Patients who are considered vulnerable or unable to provide informed consent
4. Patients with brain tumours and other primary sites not within head and neck

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Swallowing related QOL is measured using the MD Anderson Dysphagia Inventory (MDADI) at baseline, 1, 3 and 6 months<br> 2. Swallowing physiology is measured using a modified barium swallow at 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Health Related QOL is measured using FACT – QOL at baseline, 1, 3 and 6 months<br> 2. Swallowing function and Normalcy of diet is measured using the Performance Status Scale (PSS) at baseline, 1, 3 and 6 months<br>