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

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.

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