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This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer.
The primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients.
Secondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | RIANCORP
HANDYCURE PROTOCOL The Handycure device will be used at home by the patients, in addition to the usual care. Education, including written instruction sheets in how patients are to perform MLD, and use of the device will be provided. The device is to be used once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk)
Telehealth physio (wks 1, 6 and 9) post baseline will check usage, adherence and monitor safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riancorp LTU-904 Laser and Handycure® (Medical Quant) | Device | Riancorp: At the first intervention session the therapist will apply the device for 60 secs each at 14 - 25 points on the face and neck. Most patients will need application of the device at 15 to 20 points The Riancorp runs for 60 seconds, providing 1.5 j/cm2 in 60 seconds. Handycure: used by patients at home once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk) 1. Patients will apply the device for 5 minutes at each point as instructed by the physiotherapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake (trial consent rate) | Consent rate and reasons for declining trial participation | Throughout the trial for 12-months of recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Safety will be measured by the number of adverse events (AEs) related to the trial intervention and outcome assessments and reported according to the Common Terminology Criteria for Adverse Events version 5. | Throughout the trial for 12-months of recruitment |
| Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Howard | Contact | 61 3 8559 5000 | megan.howard@petermac.org | |
| Lara Edbrooke, B App Sc (Physio), GDEB, PhD | Contact | 61 3 8559 5234 | lara.edbrooke@petermac.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
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|
Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing. |
| Three months post baseline |
| Program adherence | The number of scheduled clinic and telehealth sessions attended | Throughout the trial for 12-months of recruitment and completion of 3-month follow-up |
| Program adherence | Adherence to prescribed unsupervised intervention (PBM) sessions | Throughout the trial for 12-months of recruitment and completion of 3-month follow-up |
| Retention | Patient retention at the follow-up assessment | 3-months post-baseline |
| Neck circumference | Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method | Baseline and 3-months post-baseline |
| Lymphoedema | The MD Anderson Cancer Centre Head and Neck Lymphoedema (MDACC HNL) Rating Scale will be used by the therapist to rate the degree of lymphoedema | Baseline and 3-months post-baseline |
| Percentage water content (PWC) of skin | Percentage water content of the skin to be performed using the Lymph Scanner | Baseline and 3-months post-baseline |
| Cervical spine range of motion | Neck range of motion to be measured with a digital goniometer | Baseline and 3-months post-baseline |
| Shoulder range of motion | Shoulder range of movement to be measured with a digital goniometer | Baseline and 3-months post-baseline |
| Trismus | Maximal incisal opening (trismus): The distance (in millimetres) between the edges of the maxillary and mandibular central incisors will be measured using the Therabite Range of Motion Scale. | Baseline and 3-months post-baseline |
| Health-related quality of life | EORTC QLQ-HN43 | Baseline and 3-months post-baseline |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000087525 | Radiation Fibrosis Syndrome |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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