Clinical trial NCT03030859: Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Official title: Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema
Fibrosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: National Cancer Institute (NCI)
First posted: 2017-01-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)
timeFrame: Following 3 weeks of the LEF-SCP sessions
measure: Feasibility of the LEF-SCP (Motivational Interviewing Sessions)
timeFrame: Following 3 weeks of motivational interviewing sessions
measure: Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)
timeFrame: at 12 months post-intervention
measure: Preliminary Efficacy of the LEF-SCP (Symptom Burden)
timeFrame: at 12 months post-intervention
measure: Preliminary Efficacy of the LEF-SCP (Self-Efficacy)
timeFrame: at 12 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jie Deng, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.