Clinical trial · Interventional
Home-Based Lymphedema Care Program (HBLCP) in Improving Lymphedema Self-Care in Head and Neck Cancer Survivors
Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema
NCT02170272CI-TRIAL-00031364terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to obtain funding
Summary
Brief summary (as posted)
This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-based Lymphedema Care Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Home-based Lymphedema Care Program
- description
- Home-based Lymphedema Care Program (HBLCP): Participants will undergo one training session with a lymphedema therapist, and then receive a self-care video and educational manual to review at home. After completion of training session, follow-up measures occur at 1, 2, and 3 months.
- interventionNames
- Behavioral: Home-based Lymphedema Care Program
Primary outcomes (1)
- measure
- Change in severity rate of head and neck lymphedema
- timeFrame
- Baseline to up to 3 months
- description
- Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased lymphedema severity) through measures of CTCAE, External HNLE-Fibrosis Grading Criteria, and Foldi's Scale at the study follow-ups
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * STAGE 1: * EXPERT PANEL: * A convenience sample of 10-15 experts (at least three lymphedema therapists and a varying number of HNC medical, radiation, and surgical oncologists, HNC nurse practitioners, speech and language pathologists, and nursing and informatics scientists) will be recruited to inform development of videos, protocol, and educational manual * Knowledgeable in either HNC or lymphedema management or informatics * LYMPHEDEMA THERAPISTS: * Subsequent to the development of the materials, five additional therapists will be recruited to conduct an unbiased test of the therapists' training video and protocol * Certified lymphedema therapists * Knowledgeable in head and neck lymphedema management * PATIENT PARTICIPANTS: * A convenience sample of 10 HNC survivors will be recruited to undergo a training session with the study therapist and test the patient video and educational manual * Post HNC primary treatment * No evidence of cancer (NED) * Completion of lymphedema therapy for lymphedema of the head and neck * Ability to understand English in order to complete questionnaires * Able to complete the onsite training and home self-care activities for lymphedema management * Able to provide informed consent * STAGE 2 PATIENT PARTICIPANTS: * Using the same inclusion criteria as Stage 1 a convenience sample of 30 different HNC survivors will be recruited Exclusion Criteria: * Patients with medical conditions (e.g., acute infection, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension) that would prohibit the safe implementation of home-based self-care of lymphedema will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.