Health TrialsbyHealthPanel

Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]

ConditionLymphedema of the Head and Neck
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years of age

Post HNC primary treatment

No evidence of cancer (NED)

Completion of initial lymphedema therapy for head and neck lymphedema

Disqualifiers

Recurrent or metastatic cancer

Any other active cancer

Acute infection

Acute congestive heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: Usual CareOther 1 intervention
Group B: In-Person LEF-SMPExperimental treatment 1 intervention
Group C: Telehealth LEF-SMPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in severity of lymphedema and fibrosis

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.

Time frame
Baseline, 3-, 6-, and 9-months post-intervention

Secondary outcomes

1

Changes in severity of symptom burden

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.

Time frame
Baseline, 3-, 6-, and 9-months post-intervention
2

Changes in degrees of jaw range of motion

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).

Time frame
Baseline, 3-, 6-, and 9-months post-intervention
3

Changes in degrees of cervical range of motion

This outcome measure will be assessed via Cervical Range of Motion Instrument. Higher degrees of cervical range of motion mean a better outcome.

Time frame
Baseline, 3-, 6-, and 9-months post-intervention
4

Changes in quality-of-life score

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.

Time frame
Baseline, 3-, 6-, and 9-months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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