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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030859
• Other study ID #: IRB# 828744
• Secondary ID: NCI-2016-01901
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Intervention

Other:
• Usual Care
Undergo usual care only
• 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
• 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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	American Cancer Society, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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