self-care for head and neck cancer survivors with lymphedema and fibrosis

Conditions: Head and Neck Cancer; Lymphedema; Fibrosis

Summary: 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.

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: project 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. project stage ii: patients are randomized to 1 of 3 groups. group i: patients will receive usual care only, without any additional interventions. 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 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 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.

Eligibility criteria:
inclusion criteria: * post hnc primary treatment * no evidence of cancer (ned) * no more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema * \> 18 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