Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lymphedema of the Head and Neck
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 204 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
Leer la descripción completa
In HNC survivors with lymphedema and fibrosis (LEF), the investigators will: 1) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF severity; 2) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related symptom burden, functional impairments, and quality of life; and 3) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related knowledge, skills, self-efficacy, and self-care adherence.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- \>18 years of age
- Post HNC primary treatment
- No evidence of cancer (NED)
- Completion of initial lymphedema therapy for head and neck lymphedema
- Unable to obtain lymphedema therapy due to barriers noted above
- History of lymphedema on the face and neck, with or without fibrosis
- Ability to understand English in order to complete questionnaires
- Ability to perform self-care activities for LEF management
- Ability to provide informed consent
- Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
- A valid email address
Exclusion Criteria:
- Recurrent or metastatic cancer
- Any other active cancer
- Acute infection
- Acute congestive heart failure
- Acute renal failure
- Cardiac or pulmonary edema
- Sensitive carotid sinus
- Severe carotid blockage
- Uncontrolled hypertension
- Venous thrombosis
- Pregnant people
- Incarcerated patients
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Usual Care
No informado en este registro.
Behavioral: Usual Care
In-Person LEF-SMP
No informado en este registro.
Behavioral: In-Person LEF-SMP
Telehealth LEF-SMP
No informado en este registro.
Behavioral: Telehealth LEF-SMP
Usual Care BEHAVIORAL
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
In-Person LEF-SMP BEHAVIORAL
Participants will receive the in-person LEF-SMP intervention.
Telehealth LEF-SMP BEHAVIORAL
Participants will receive the telehealth LEF-SMP intervention.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Changes in severity of lymphedema and fibrosis
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). The total severity score of lymphedema and fibrosis (LEF) is calculated by summing the severity score (normal = 0, mild =1, moderate =2, and severe =3) of each anatomical site affected by head and neck LEF. Higher scores mean a worse outcome.
Medidas secundarias
Changes in severity of symptom burden
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory). The severity score of symptom burden is dependent on the number of self-reported symptoms \[overall score range: 0 (no) - 5 (severe)\], and higher scores mean a worse outcome.
Changes in degrees of jaw range of motion
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Jaw Range of Motion Scale. Higher degrees of jaw range of motion mean a better outcome (criteria for trismus: mouth opening \< 35mm).
Changes in degrees of cervical range of motion
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Cervical Range of Motion Instrument. Higher degrees of cervical range of motion mean a better outcome.
Changes in quality-of-life score
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire includes a global health-related quality of life scale, 5 functional subscales, 3 symptom scales, and 6 single items. Scores for all scales and single items are linearly converted to range from 0-100, and higher scores signify a higher quality of life.
Changes in LEF-related knowledge score
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
LEF-related knowledge will be assessed via HN-LEF Knowledge Test scale. The scale asks participants to answer 35 true/false questions. The total score (score range: 0-35) represents participants' knowledge level related to head and neck LEF, and higher scores mean a better outcome.
Changes in LEF-related skills
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
LEF-related skills will be assessed via HN-LEF Skill Checklist. Study lymphedema therapists use this checklist to evaluate participants' LEF self-care skills.
LEF-related self-efficacy score
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
LEF-related self-efficacy will be assessed via Perceived Medical Condition Self-Management Scale \[8-item, each item score 1 (strongly disagree) - 5 (strongly agree)\]. Higher scores indicate greater self-efficacy.
LEF-related self-care adherence status
Plazo: Baseline, 3-, 6-, and 9-months post-intervention
LEF-related self-care adherence will be assessed via LEF Self-Care Checklist. Higher scores indicate greater better adherence to LEF self-care activities (i.e., full adherence: ≥ 5 days; partial adherence: 3-4 days; non-adherence: \<3 days).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
2 centros
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesReclutando
Vanderbilt University Medical CenterNashville, Tennessee, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Abramson Cancer Center at Penn Medicine
- Inicio del estudio
- 29 mar 2024 Real
- Finalización primaria
- 31 ago 2027 Estimado
- Finalización del estudio
- 31 ago 2027 Estimado
- Primera publicación
- 9 nov 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026