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

NCT03030859 | Completed Results DMC

• 2 other identifiers: IRB# 828744NCI-2016-01901
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Lymphedema; Fibrosis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Group I (Usual Care)

EXPERIMENTAL

Patients receive usual care only, without any additional interventions.

Other: Usual Care

Group II (Usual Care plus LEF-SCP)

EXPERIMENTAL

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

Group III (Usual Care plus LEF-SCP plus Follow-Up)

EXPERIMENTAL

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

Interventions

Usual Care OTHER

Undergo usual care only

Group I (Usual Care)

Usual Care plus LEF-SCP OTHER

Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos

Group II (Usual Care plus LEF-SCP)

Usual Care plus LEF-SCP plus Follow-up OTHER

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

Group III (Usual Care plus LEF-SCP plus Follow-Up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• American Cancer Society, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Deng J, Murphy BA, Andersen LP, McMenamin E, Lukens JN, Cohn JC, Rajasekaran K, Quinn RJ, Spinelli BA, Lin A. Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized controlled trial. Oral Oncol. 2025 Sep;168:107556. doi: 10.1016/j.oraloncology.2025.107556. Epub 2025 Aug 6.

  PMID: 40773982 DERIVED

• 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.

  PMID: 36348346 DERIVED

• 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.

  PMID: 31882012 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphedema; Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot study with the small number of participants.

Results Point of Contact

• Title: Jie Deng, PhD, PI
• Organization: University of Pennsylvania School of Nursing

jiedeng@nursing.upenn.edu

215-573-2393

Study Officials

• Jie Deng, PhD, RN

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 25, 2017
• Study Start: June 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 11, 2024
• Results First Posted: April 11, 2024

Record last verified: 2024-03

Locations

US (1)