Clinical trial · Interventional
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
NCT03030859CI-TRIAL-00075938completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosis | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Usual Care | Other | — | UNRESOLVED |
| Usual Care plus LEF-SCP | Other | — | UNRESOLVED |
| Usual Care plus LEF-SCP plus Follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I (Usual Care)
- description
- Patients receive usual care only, without any additional interventions.
- interventionNames
- Other: Usual Care
- type
- EXPERIMENTAL
- label
- Group II (Usual Care plus LEF-SCP)
- description
- Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
- interventionNames
- Other: Usual Care plus LEF-SCP
- type
- EXPERIMENTAL
- label
- Group III (Usual Care plus LEF-SCP plus Follow-Up)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Post HNC primary treatment * No evidence of cancer (NED) * No more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema * \> 18 years of age * Ability to understand English in order to complete questionnaires * Able to complete the onsite training and home self-care activities for LEF management * Able to provide informed consent Exclusion Criteria: • Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
References
Publications (3)
- DERIVEDDeng J, Murphy BA, Andersen LP, McMenamin E, Lukens JN, Cohn JC, Rajasekaran K, Quinn RJ, Spinelli BA, Lin A. Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized controlled trial. Oral Oncol. 2025 Sep;168:107556. doi: 10.1016/j.oraloncology.2025.107556. Epub 2025 Aug 6. PMID 40773982
- DERIVEDDeng J, Lukens JN, Cohn JC, McMenamin E, Murphy B, Spinelli BA, Murphy N, Steinmetz AK, Landriau MA, Lin A. Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies. Trials. 2022 Nov 8;23(1):927. doi: 10.1186/s13063-022-06804-w. PMID 36348346
- DERIVEDDeng J, Dietrich MS, Murphy B. Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):775. doi: 10.1186/s13063-019-3819-0. PMID 31882012