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Completed

NCT Number: NCT03030859

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.

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Key information

Conditions

Head and Neck Cancer Fibrosis Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

Undergo usual care only

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

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

Primary outcomes

  1. Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)

    Time frame: 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.

  2. Feasibility of the LEF-SCP (Motivational Interviewing Sessions)

    Time frame: 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.

  3. Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)

    Time frame: 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).

  4. Preliminary Efficacy of the LEF-SCP (Symptom Burden)

    Time frame: 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.

  5. Preliminary Efficacy of the LEF-SCP (Self-Efficacy)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2017
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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