Self-Management Program for Head & Neck Cancer-related Lymphedema
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Disqualifiers: Recurrent cancer, Metastatic cancer, Infection, Heart failure, Renal failure, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment LEF-SMP, Lymphedema and Fibrosis Self-Management Program, for head and neck cancer-related lymphedema?
Is the Self-Management Program for Lymphedema safe for humans?
How is the LEF-SMP treatment different from other treatments for head and neck cancer-related lymphedema?
Eligibility Criteria
This trial is for adults over 18 who have survived head and neck cancer, are currently free of cancer, and have completed initial therapy for lymphedema in the face and neck. Participants must be able to manage their own care, understand English, have internet access with an electronic device at home, and a valid email address.Inclusion Criteria
You need to be able to understand English to answer questions.
I am 18 years old or older.
I have completed my initial treatment for head and neck cancer.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either in-person LEF-SMP, telehealth LEF-SMP, or usual care to manage lymphedema and fibrosis
3 months
Regular visits as per intervention type
Follow-up
Participants are monitored for changes in LEF severity, symptom burden, self-efficacy, and quality of life
6 months
Assessments at 3, 6, and 9 months post-intervention
Treatment Details
Interventions
- LEF-SMP (Behavioral Intervention)
Trial OverviewThe PROMISE Trial is testing how effective a standardized self-management program (LEF-SMP) is when delivered via telehealth or in-person compared to usual care. It aims to improve self-care for lymphedema and fibrosis among head and neck cancer survivors.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: Telehealth LEF-SMPExperimental Treatment1 Intervention
Group III: In-Person LEF-SMPExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Barbara MurphyNashville, TN
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
United States Department of DefenseCollaborator
References
Refinement and Validation of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. [2022]Lymphedema and fibrosis (LEF) are common yet overlooked late effects of head and neck cancer and its therapy. Lack of reliable and valid measures of head and neck LEF is a critical barrier to the timely identification and management of head and neck LEF. To fill this gap, we developed and pilot tested a 64-item patient-reported outcome measure ( Lymphedema Symptom Intensity and Distress Survey-Head and Neck, LSIDS-H&N). This article aims to report the process of further validation and refinement of the tool.
Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. [2023]Head and neck cancer (HNC) patients are at high risk for developing lymphedema and fibrosis (LEF) following cancer treatment. Once HNC patients develop LEF, they need to conduct life-long self-care to slow LEF progression and reduce associated symptom burden and functional deficits. Data demonstrate that inadequate LEF self-care may be a potentially remediable issue. The objective of this study is to explore the feasibility and preliminary efficacy of an Information-Motivation-Behavioral (IMB) Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments.
The effect of a self-management lymphedema education program on lymphedema, lymphedema-related symptoms, patient compliance, daily living activities and patient activation in patients with breast cancer-related lymphedema: A quasi-experimental study. [2022]This study was undertaken to determine the effects of self-management lymphedema education program (SMLEP) on lymphedema, lymphedema-related symptoms, patient compliance, activities of daily living (ADL) and patient activation in patients with breast cancer-related lymphedema (BCRL).
Strategies in activating lymphatic system to promote lymph flow on lymphedema symptoms in breast cancer survivors: A randomized controlled trial. [2022]Label="Background" NlmCategory="UNASSIGNED">Many breast cancer survivors face long-term postoperative challenges as a result of developing lymphedema symptoms and chronic lymphedema. The-Optimal-Lymph-Flow (TOLF) program is an intervention based on physiological-cognitive-behavioral principles that teaches patients self-management strategies to activate lymphatic system and promote lymph flow to decrease lymphatic pain, reduce the risk and severity of lymphedema.
Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. [2021]Early intervention with self-management strategies can potentially reduce the risk of progression of breast cancer-related lymphedema (BCRL).
Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria. [2022]Measurement of head and neck external lymphedema and fibrosis (LEF) is challenging. To address this gap, we developed the Head and Neck External Lymphedema and Fibrosis (HN-LEF) Assessment Criteria. This article aimed to report preliminary data on reliability and validity of the HN-LEF Assessment Criteria.
Validity Testing of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. [2023]Background: Lack of reliable and valid tools significantly impacts early identification and timely treatment of lymphedema and fibrosis (LEF) in the head and neck cancer population. To address this need, we developed and reported a patient-reported outcome measure (Head and Neck Lymphedema and Fibrosis Symptom Inventory [HN-LEF SI]). This article reports the construct validity (convergent and divergent validity) testing of the tool. Materials and Methods: A prospective, longitudinal, instrument validation study was conducted in patients with a newly diagnosed oral cavity or oropharyngeal cancer. Participants completed the HN-LEF SI and six carefully selected self-report measures at pretreatment, end-of-treatment, and every 3 months up to 12 months after treatment. Spearman correlations were used. Results: A total of 117 patients completed the study. Patterns of correlations of the HN-LEF SI scores with the established self-report measure scores were consistent with expected convergent and divergent validity. Conclusion: Evidence from this work supports the construct validity of the HN-LEF SI.
Treatment and outcomes of head and neck oedema referrals to a hospital-based lymphoedema service. [2015]A retrospective review of all head and neck cancer-related lymphoedema (HNCRL) referrals from 1 October 2009 to 30 September 2013 was undertaken. HNCRL referrals significantly increased over a 4-year period. Lymphoedema clinic records were manually examined for the presentation of HNCRL, treatments provided, and outcomes. Some 207 HNCRL referrals were received, increasing by 251% from 2009 to 2013. A total of 110 men and 50 women were assessed and treated over the 4 years; 67% were discharged, 26% continued treatment/monitoring by clinic; 8% are deceased. The average time to discharge reduced from 16 to 5 months. From the results, it seems that self-management with exercise and counter-pressure/compression is very effective and the requirement for manual lymph drainage is reduced. There is increased patient engagement with effective self-care. Provision of appropriate education and information facilitated simple, effective self-management. This reduced treatment time, shortened time to discharge and released valuable practitioner time to treat patients with complex oedema.
Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. [2022]Lymphedema after treatment for head and neck cancer negatively impacts the quality of life and can produce neck tissue stiffness, dysphagia, pain, and swelling. One form of treatment for lymphedema is machine-delivered sequential lymphedema massage, which is home based and self administered. This study was undertaken to determine economic and system access to home-based lymphedema therapy and to measure patient-reported outcomes among those able to access therapy.