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

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ClinicalTrials.gov Identifier: NCT03030859
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
American Cancer Society, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jie Deng, 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lymphedema Fibrosis Other: Usual Care Other: Usual Care plus LEF-SCP Other: Usual Care plus LEF-SCP plus Follow-up Not Applicable

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:

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.

STAGE II: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive monthly automated system telephone call for 12 month.

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 receive monthly automated system telephone call for 12 months. 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 receive monthly automated system telephone call for 12 months. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (Usual Care)
Patients receive monthly automated system telephone call for 12 months.
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 receive monthly automated system telephone call for 12 months. 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 receive monthly automated system telephone call for 12 months. 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




Primary Outcome Measures :
  1. Feasibility of the LEF-SCP evaluated by Recruitment Log [ Time Frame: Up to 12 months ]
    Descriptive statistical methods will be used to summarize the rates of participation.

  2. Self-efficacy assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) [ Time Frame: Up to 12 months ]
    Descriptive statistical methods will be used to summarize the PMCSMS score.

  3. Self-care adherence evaluated by Self-Care Checklist [ Time Frame: Up to 12 months. ]
    Descriptive statistical and graphical methods will be used to describe the number and types of self-care activities.

  4. Preliminary efficacy assessed by LEF status [ Time Frame: Up to 12 months ]
    Mixed effects generalized linear models with the appropriate link function for the nature of the specific outcome variable being analyzed will be used to generate estimates of the effect of the LEF-SCP on the progression of head and neck LEF.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STAGE I
  • Post HNC primary treatment
  • No evidence of cancer (NED)
  • No more than 6 weeks after completion of initial lymphedema therapy for head and neck lymphedema
  • > 21 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
  • STAGE II
  • Eligibility criteria same as stage I
  • Stage I participants are ineligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030859


Contacts
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Contact: University of Pennsylvania Clinical Trials Office 215-349-5537

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jie Deng, PhD, RN, FAAN    215-573-2393      
Sponsors and Collaborators
University of Pennsylvania
American Cancer Society, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jie Deng, PhD, RN University of Pennsylvania

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Responsible Party: Jie Deng, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03030859     History of Changes
Other Study ID Numbers: IRB# 828744
NCI-2016-01901 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Head and Neck Neoplasms
Lymphedema
Pathologic Processes
Neoplasms by Site
Neoplasms
Lymphatic Diseases