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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema.
Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status.
Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-Based Lymphedema Therapy | Active Comparator |
| |
| Home-Based (a hybrid model) Lymphedema Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based (a hybrid model) CDT | Other | Participants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in severity of lymphedema | Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in severity of symptom burden | Compare the effects of clinic-based and home-based CDT on changes in the severity of symptom burden. This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory) | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare utilization | Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study. | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
| Healthcare utilization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Cherry Hospital Jefferson Health | Cherry Hill | New Jersey | 08002 | United States | ||
| University of Pennsylvania |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C056759 | carbohydrate-deficient transferrin |
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| Clinic-based CDT | Other | Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions). |
|
| Changes in degrees of jaw range of motion | Compare the effects of clinic-based and home-based CDT on jaw range of motion. Jaw range of motion will be measured via Jaw Range of Motion Scale. | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
| Changes in degrees of cervical range of motion | Compare the effects of clinic-based and home-based CDT on cervical range of motion. Cervical Range of Motion will be measured via Cervical Range of Motion Instrument. | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study. |
| Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Jefferson Health | Philadelphia | Pennsylvania | 19107 | United States |
| Jefferson Torresdale Hospital Jefferson Health | Philadelphia | Pennsylvania | 19114 | United States |
| Temple University Hospital and Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19140 | United States |
| Asplundh Cancer Pavilion Jefferson Health | Willow Grove | Pennsylvania | 19090 | United States |