NCT03030859

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Lymphedema
• Fibrosis

Interventions

Type	Name	Description
OTHER	Usual Care	Undergo usual care only
OTHER	Usual Care plus LEF-SCP	Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
OTHER	Usual Care plus LEF-SCP plus Follow-up	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

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2017-01-25
• Last updated: 2024-04-11
• Results posted: 2024-04-11

Locations

1 site across 1 country: United States