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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Lymphedema; Fibrosis
• Interventions: Other: Usual Care; Other: Usual Care plus LEF-SCP; Other: Usual Care plus LEF-SCP plus Follow-up

• Registration Number: NCT03030859
• Lead Sponsor: University of Pennsylvania

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-22
• Study First Posted: 2017-01-25
• Study Start: 2018-06-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Results First Submitted: 2023-02-27
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-04-11
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Usual Care)	Usual Care	Patients receive usual care only, without any additional interventions.
Group II (Usual Care plus LEF-SCP)	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.
Group III (Usual Care plus LEF-SCP plus Follow-Up)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)	Following 3 weeks of the LEF-SCP 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.
Feasibility of the LEF-SCP (Motivational Interviewing Sessions)	Following 3 weeks of 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.
Preliminary Efficacy of the LEF-SCP (Symptom Burden)	at 12 months post-intervention	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.
Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)	at 12 months post-intervention	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).
Preliminary Efficacy of the LEF-SCP (Self-Efficacy)	at 12 months post-intervention	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States