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The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exercise intervention | Experimental | The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated. |
|
| Control | No Intervention | The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive physical exercise | Behavioral | Daily physical activity depending on daily condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objectively measured physical activity | Measured with an accelerometer. Measures time spent in different activities i minutes/day. | Up to 12 months |
| Subjectively measured physical activity - Saltin-Grimby | Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire. | Up to 12 months |
| Subjectively measured physical activity (IPAQ) | Measured with the International Physical Activity Questionnaire | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (HRQL) using the EORTC QLQ-C30 | Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | The cost of intervention compared to usual care. Costs in Swedish crowns (SEK) for the intervention and all visits to healthcare during 5 years will be recorded. | Up to 5 years post radiotherapy |
| Quality of life for cost-effectiveness analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Tuomi, PhD | Contact | +46313421000 | tuomi.lisa@gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Tuomi, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001519 | Behavior |
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| Up to 5 years post radiotherapy |
| Health related quality of life (HRQL) using the EORTC QLQ H&N35 | Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL. | Up to 5 years post radiotherapy |
| Trismus and jaw related symptoms | Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms. | Up to 5 years post radiotherapy |
| Dysphagia related symtoms | PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome. | Up to 5 years post radiotherapy |
| Maximal Interincisal opening (MIO) | Jaw opening measured in millimeters | Up to 5 years post radiotherapy |
| Body composition | Bioelectric impedance analysis. | Up to 12 months post radiotherapy |
| Grip strength | Measured with the a hand dynamometer | Up to 12 months post radiotherapy |
| 6-minute walking test | Measures total walking distance during 6 minutes. | Up to 12 months post radiotherapy |
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
| Up to 5 years post radiotherapy |
| Quality Adjusted Life Years (QALY) | QALY is a measurement that combines health-related quality of life (HRQL) and life expectancy in one index. The index range between 0 and 1, where 0 equals death and 1 represents perfect health. Thus, 1 QALY corresponds to 1 year of perfect health. This is calculated using the EQ-5D. | Up to 5 years post radiotherapy |
| Incremental Cost Effectiveness Ratio (ICER) | Incremental cost for each QALY for the intervention group will be calculated using a Markov model which combines the costs and EQ-5D. The ICER will then be compared to the maximum willingness to pay level which is SEK 500,000 (€55,000) according to the Swedish National Board of Health and Welfare. | Up to 5 years post radiotherapy |