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

A study of Head and Neck Cancer and Lymphedema, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Cancer, Lymphedema, Fibrosis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2018to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Head and Neck Cancer, Lymphedema, Fibrosis
Being tested: Usual Care, Usual Care plus LEF-SCP, Usual Care plus LEF-SCP plus Follow-up
Medical subject headings: Head and Neck Neoplasms, Lymphedema, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual CareOther
Undergo usual care only
Usual Care plus LEF-SCPOther
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-upOther
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

Study groups in NCT03030859
Study group	Role	What they receive
Group I (Usual Care)	Experimental	Patients receive usual care only, without any additional interventions. Receives: 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. Receives: 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. Receives: Other: Usual Care plus LEF-SCP plus Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: at 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201831 Mar 2022

First posted25 Jan 2017 (estimated)
Study start1 Jun 2018
Primary completion31 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Head and Neck CancerStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03030859
Sponsor's protocol ID: IRB# 828744
Other IDs: NCI-2016-01901
Status last verified: Mar 2024
First submitted: 30 Dec 2016
Last updated: 11 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 40773982
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.
PubMed 36348346
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.
PubMed 31882012

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
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RecruitingPhase 4
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Head and Neck Cancer (H&N)

All Head and Neck Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
ClinicalTrials.gov ID: NCT03030859
Acronym / sponsor ID: IRB# 828744
Conditions: Head and Neck Cancer, Lymphedema, Fibrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: American Cancer Society, Inc., National Cancer Institute (NCI)
Study start: 1 Jun 2018 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 25 Jan 2017 (estimated)
Results: Posted 11 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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)

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)

OUTLINE:

Project Stage II: Patients are randomized to 1 of 3 groups.

GROUP I: Patients will receive usual care only, without any additional interventions.

After completion of study, patients are followed up at 3, 6, 9, and 12 months.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group I (Usual Care)	Experimental	Other: Usual CarePatients receive usual care only, without any additional interventions.
Group II (Usual Care plus LEF-SCP)	Experimental	Other: Usual Care plus LEF-SCPPatients 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)	Experimental	Other: Usual Care plus LEF-SCP plus Follow-upPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Usual CareUndergo usual care only	Other	Group I (Usual Care)
Usual Care plus LEF-SCPUndergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos	Other	Group II (Usual Care plus LEF-SCP)
Usual Care plus LEF-SCP plus Follow-upUndergo 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	Other	Group III (Usual Care plus LEF-SCP plus Follow-Up)

Primary outcome

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.
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.
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).
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.
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.

Results and safety

Results posted to the registry on 11 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Usual Care)	20	19
Group II (Usual Care Plus LEF-SM Program)	20	17
Group III (Usual Care Plus LEF-SM Program Plus Follow-Up With a Lymphedema Therapist)	19	13

Primary outcome: Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)

Time frame: Following 3 weeks of the LEF-SCP sessions. Count of participants. Unit: Participants

Measure	Group II (Usual Care Plus LEF-SCP) n = 20	Group III (Usual Care Plus LEF-SCP Plus Follow-Up) n = 19
Value	20	18

Primary outcome: Feasibility of the LEF-SCP (Motivational Interviewing Sessions)

Time frame: Following 3 weeks of motivational interviewing sessions. Count of participants. Unit: Participants

Measure	Group II (Usual Care Plus LEF-SCP) n = 20	Group III (Usual Care Plus LEF-SCP Plus Follow-Up) n = 18
Value	20	16

Primary outcome: Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)

Time frame: at 12 months post-intervention. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Group 1 n = 19	Group 2 n = 20	Group 3 n = 16
Value	-0.11 (-1.01 to 0.80)	-2.35 (-3.51 to -1.19)	-2.25 (-3.91 to -0.59)

Primary outcome: Preliminary Efficacy of the LEF-SCP (Symptom Burden)

Time frame: at 12 months post-intervention. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Group 1 n = 19	Group 2 n = 20	Group 3 n = 16
Value	-0.15 (-0.49 to 0.19)	-0.73 (-1.21 to -0.24)	-0.53 (-1.06 to -0.01)

Adverse events

Time frame: Adverse event data were collected for 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Usual Care)	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Group II (Usual Care Plus LEF-SCP)	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): This was a pilot study with the small number of participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40773982Deng 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.
Derived from this study: PubMed 36348346Deng 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.
Derived from this study: PubMed 31882012Deng 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.
Individual participant dataSharing planned: Undecided

Related trials for Head and Neck Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Deng, PhD, RN principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Head and Neck Cancer and Lymphedema, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) (time frame: Following 3 weeks of the LEF-SCP sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030859, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.