A study to help people with swallowing after treatment for head and neck cancer

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Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasal and paranasal sinus cancer
Nasopharyngeal cancer
Pharyngeal cancer
Salivary gland cancer

Status:

Results

Phase:

Other

Most people have difficulty swallowing after surgery or radiotherapy to treat a head and neck cancer. This can be a long term problem. 

Part 1 of this study was open for people to join between October 2014 and January 2015. Part 2 of this study was open for people to join between April and December 2016. The results were published in 2017.

More about this trial

Before and after treatment for a head and neck cancer you see a speech and language therapist to get help with swallowing. They can give you exercises to do and some guidance about how to cope. 

This study developed a new package to help with swallowing. The people taking part had x-rays to see how they swallowed. Based on the x-rays the speech and language therapist gave them exercises specifically designed for each person. 
        
This study had 2 parts.
 
Part 1 was open to people who had treatment for a head and neck cancer. In this part, the study team asked people about their experiences of difficulty with swallowing after treatment. They used this to help them develop the package. 

Part 2 was open to people who were to have treatment for mouth (oral) cancer or a cancer of the back of the mouth and nose (pharynx). This part was a feasibility study

In this part the researchers gave the new swallowing package to a small number of people. This was to further develop the swallowing package to use in a large clinical trial. 

Summary of results

In Part 1 the team found out about people’s experiences doing the exercises to help with their swallowing. From this they developed the Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training (SIP SMART).  

In Part 2 they found it was possible to do a clinical trial Open a glossary item comparing SIP SMART with the standard care to help with difficulty swallowing after treatment.  

About Part 1 of the study
The study team interviewed 13 people with a head and neck cancer. They were between 3 months and 18 months after finishing treatment. The questions they asked included:

  • the person’s knowledge about swallowing exercises
  • the ease of carrying out the exercises
  • their opinions, views and feelings about the exercises
  • the support they had to do the exercises

Results for Part 1
From the interviews the team identified what stopped people doing the swallowing exercises (barriers) and what helped (facilitators).

Barriers and Facilitators 
The team identified 3 areas where there were barriers and facilitators to doing the exercises. 
 
Capability
This is the ability and willingness to do the exercises. This was looking at whether they were able do the exercises and whether they would do them. 

People said they had got the information about the exercises and how to do them. But not about why it was important to do them. There was a feeling that the exercises before treatment were only a safeguard. They didn’t believe that they needed to do them. 

Another barrier was the number of different things that they needed to do and remember during treatment. And the difficulty of knowing which was most important. They felt the team told them a lot of information. They also received a lot of information to read. And they felt overwhelmed by the amount of information. 

Side effects such as pain, feeling sick and having sticky mucus in the mouth were also a barrier. 

What helped was that people felt the exercises were simple and easy to do once:

  • they knew how to do them
  • they were confident they were doing them correctly 

Some people found it helpful to keep a record (track) of doing the exercises. Some used a chart and others used their smartphone. 

Opportunity
The opportunity to do the exercises wasn’t reported as a common barrier. But some were not keen to do them in front of their young children. Some felt they could do them anywhere but others preferred a private place. 

Some people felt the information about the exercises needed improvement for example using pictures. This could give a better understanding of the exercises and how to do them. 

Family support and encouragement helped people to continue doing the exercises.

Motivation
An important part of motivation is the belief that you can overcome an obstacle. For some people the obstacles included:

  • the feeling that there was too much to do 
  • uncertainty about the need to do them, especially if the exercises start before the treatment to prevent problems later 

People felt rewarded by small improvements to their swallowing. And this motivated them to continue.

Conclusion of Part 1
These results suggest there is capacity for improvement in all 3 areas. But the greatest shift needs to be in the ability and willingness to do the exercises (capability area).  

Understanding what helped people do the exercises and the barriers can help develop new swallowing programmes for people with head and neck cancers. 

About Part 2 of the study
This was a feasibility study. It was a randomised study. Everyone who took part was put into 1 of 2 groups. Neither they or their doctor chose which group they were in. This part of the trial was to find:

  • out if the swallowing package could be used in a large clinical trial
  • if people were willing to take part
  • if people were willing to be put into a group at random (randomised)
  • if people were willing to do the follow up

Results of Part 2
People in group 1 used SIP SMART. This involved two 45 minute sessions that included:

  • an assessment of swallowing 
  • appropriate specific education and information material
  • targeted swallowing exercises
  • detailed plans of behaviour to increase sticking to the swallowing exercises

People in group 2 had the usual care. This was a single session that included:

  • an assessment of swallowing
  • general information material

The medical team identified 106 people who might have been able to join the study. Of these the study team assessed 70 people to join the study:

  • 26 people weren’t suitable to take part
  • 5 people were missed in the clinic
  • 7 people declined to join the study
  • 32 people joined the study 

32 people was the target that the researchers wanted to achieve. 

After 6 months 29 people remained in the study. 

The researchers found that:

  • people accepted being put into their groups at random
  • people were positive about doing the exercises
  • the time people kept doing the exercises went beyond the minimum time they expected 

There were no side effects or complications from doing the exercises. 

The team found that the tool they used to measure the people’s quality of life Open a glossary item during the study was suitable. 

Conclusion for Part 2
The team concluded that it was feasible to do a conclusive clinical trial comparing SIP SMART to usual care for people with head and neck cancer. And they were able to do it as part of their treatment pathway in the NHS. 

Where this information comes from    
For Part 1
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

For Part 2
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal.  The figures we quote above were provided by the research team. We have not analysed the data ourselves. 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Stuart Taylor

Supported by

NIHR Clinical Research Network: Cancer
University College London (UCL)
NIHR Fellowships Programme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12562

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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