Head and Neck Cancer, Lymphedema
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERHome-based (a hybrid model) CDT
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.
OTHERClinic-based CDT
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
Sponsors
Abramson Cancer Center at Penn Medicine
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years of age * \<=24 months post-HNC treatment * Diagnosis of head and neck lymphedema and referral by their oncology providers * Able to perform self-manual lymphatic drainage * Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home
Exclusion criteria
* Active infection in soft tissues in the head and neck region * History of moderate or severe carotid artery occlusion * Significantly severe lymphedema (e.g., severe periorbital swelling) * Conditions impacting the safe delivery of lymphedema therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in severity of lymphedema | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in severity of symptom burden | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 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) |
| Changes in degrees of jaw range of motion | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 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. |
| Changes in degrees of cervical range of motion | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 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. |
Countries
United States
Outcome results
None listed