Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors (LEF-self-care program [SCP]) with the goal of improving LEF associated outcomes when compared to usual care alone. (Stage I) II. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction. (Stage II) III. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and adherence compared to usual care in HNC survivors with LEF. (Stage II) IV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and 3) functional status. (Stage II) OUTLINE: STAGE I: Patients undergo a training session with the study lymphedema therapist and review the educational manual and videos for the development of all three components of the LEF self-care program. STAGE II: Patients are randomized to 1 of 3 groups. GROUP I: Patients receive monthly automated system telephone call for 12 month. GROUP II: Patients undergo LEF-SCP training comprising of motivational interview (MI) session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. GROUP III: 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 receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months. After completion of study, patients are followed up at 3, 6, 9, and 12 months.

Official Title
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Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Conditions
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Head and Neck Cancer, Lymphedema, Fibrosis

Intervention / Treatment
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* Other: Usual Care
* Other: Usual Care plus LEF-SCP
* Other: Usual Care plus LEF-SCP plus Follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STAGE I Post HNC primary treatment No evidence of cancer (NED) No more than 6 weeks after completion of initial lymphedema therapy for head and neck lymphedema > 21 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 STAGE II Eligibility criteria same as stage I Stage I participants are ineligible

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Usual Care)<br>Patients receive monthly automated system telephone call for 12 months. | Other: Usual Care<br>* Undergo usual care only<br>|
| Experimental: Group II (Usual Care plus LEF-SCP)<br>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 receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. | Other: Usual Care plus LEF-SCP<br>* Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos<br>|
| Experimental: Group III (Usual Care plus LEF-SCP plus Follow-Up)<br>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 receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months. | Other: Usual Care plus LEF-SCP plus Follow-up<br>* Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the LEF-SCP evaluated by Recruitment Log | Descriptive statistical methods will be used to summarize the rates of participation. | Up to 12 months | 
| Self-efficacy assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) | Descriptive statistical methods will be used to summarize the PMCSMS score. | Up to 12 months | 
| Self-care adherence evaluated by Self-Care Checklist | Descriptive statistical and graphical methods will be used to describe the number and types of self-care activities. | Up to 12 months. | 
| Preliminary efficacy assessed by LEF status | Mixed effects generalized linear models with the appropriate link function for the nature of the specific outcome variable being analyzed will be used to generate estimates of the effect of the LEF-SCP on the progression of head and neck LEF. | Up to 12 months |