Recurrent Oropharynx Carcinoma
Conditions
Brief summary
The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.
Interventions
OTHERTreatment for recurrent oropharyngeal cancer (curative/ palliative)
Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy.
Sponsors
Imperial College London
Royal Marsden NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adult (aged 18 years or over) competent to provide consent * Have a diagnosis of recurrent OPC * Have adequate linguistic and cognitive function to participate in interview * English speaking
Exclusion criteria
* Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Swallowing Related Quality of Life | Baseline, 3 months, 6 months | Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head & neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing Status Measured Using the 100ml Water Swallow Test | Baseline, 3 months, 6 months | The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task. |
| Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) | Baseline, 3 months, 6 months | The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew) A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score |
Countries
United Kingdom
Participant flow
Pre-assignment details
Difficulties recruiting participants to the study, number recruited will be adequate for analysis and will meet criteria for primary endpoint
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Patients with a diagnosis of recurrent oropharyngeal cancer - prospective | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 64 YEARS |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United Kingdom | 25 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 25 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Patient Reported Swallowing Related Quality of Life
Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head & neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 | Patient Reported Swallowing Related Quality of Life | Baseline | 50 score on a scale |
| Group 1 | Patient Reported Swallowing Related Quality of Life | 3 months | 40 score on a scale |
| Group 1 | Patient Reported Swallowing Related Quality of Life | 6 months | 40 score on a scale |
Secondary
Swallowing Status Measured Using the 100ml Water Swallow Test
The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task.
Time frame: Baseline, 3 months, 6 months
Population: Some participants were unable to complete/did not wish to complete the water swallow test
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 | Swallowing Status Measured Using the 100ml Water Swallow Test | Baseline | 9.7 ml/second |
| Group 1 | Swallowing Status Measured Using the 100ml Water Swallow Test | 3 months | 16.6 ml/second |
| Group 1 | Swallowing Status Measured Using the 100ml Water Swallow Test | 6 months | 17.9 ml/second |
Secondary
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew) A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score
Time frame: Baseline, 3 months, 6 months
Population: Not all participants completed the questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 | Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) | Baseline | 7 score on a scale |
| Group 1 | Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) | 3 months | 6 score on a scale |
| Group 1 | Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS) | 6 months | 6 score on a scale |