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

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.

Study Overview

• Status: Completed
• Conditions: Fibrosis; Head and Neck Cancer; Lymphedema
• Intervention / Treatment: Other: Usual Care; Other: Usual Care plus LEF-SCP; Other: Usual Care plus LEF-SCP plus Follow-up

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Usual Care); Patients receive usual care only, without any additional interventions.	Other: Usual Care; Undergo usual care only
Experimental: Group II (Usual Care plus LEF-SCP); 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 also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.	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
Experimental: Group III (Usual Care plus LEF-SCP plus Follow-Up); 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)	Feasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.	Following 3 weeks of the LEF-SCP sessions
Feasibility of the LEF-SCP (Motivational Interviewing Sessions)	Feasibility of the LEF-SCP was evaluated by number of participants that completed the motivational interviewing sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.	Following 3 weeks of motivational interviewing sessions
Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)	Change in total severity of external LEF from baseline to 12 months post-intervention. A larger change in this score means more reduction in the severity of external LEF, External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).	at 12 months post-intervention
Preliminary Efficacy of the LEF-SCP (Symptom Burden)	Change in symptom burden score from baseline to 12 months post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (soft tissue and neurologic toxicity) score is reported here.	at 12 months post-intervention
Preliminary Efficacy of the LEF-SCP (Self-Efficacy)	Change in self-efficacy score from baseline to 12 months post-intervention. A larger change in this score means increased self-efficacy. Self-efficacy is assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) (8-item). Higher scores (score ranging from 8-40) indicate greater self-efficacy.	at 12 months post-intervention

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Cancer Institute (NCI); American Cancer Society, Inc.
• Investigators: Principal Investigator: Jie Deng, PhD, RN, University of Pennsylvania

Publications and helpful links

General Publications

• Deng J, Lukens JN, Cohn JC, McMenamin E, Murphy B, Spinelli BA, Murphy N, Steinmetz AK, Landriau MA, Lin A. Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies. Trials. 2022 Nov 8;23(1):927. doi: 10.1186/s13063-022-06804-w.
• Deng J, Dietrich MS, Murphy B. Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):775. doi: 10.1186/s13063-019-3819-0.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: January 22, 2017
• First Posted (Estimated): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Fibrosis; Head and Neck Neoplasms; Lymphedema
• Other Study ID Numbers: IRB# 828744; NCI-2016-01901 (Registry Identifier: NCI, Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No