CompletedNot Applicable

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

United States59 participantsStarted 2018-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Following 3 weeks of the LEF-SCP sessions

Feasibility of the LEF-SCP (Motivational Interviewing Sessions)

Timeframe: Following 3 weeks of motivational interviewing sessions

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

Timeframe: at 12 months post-intervention

Preliminary Efficacy of the LEF-SCP (Symptom Burden)

Timeframe: at 12 months post-intervention

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

Timeframe: at 12 months post-intervention

Trial details

NCT IDNCT03030859

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

Results submitted2023-02-27

View on ClinicalTrials.gov More Head and Neck Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Following 3 weeks of the LEF-SCP sessions

Feasibility of the LEF-SCP (Motivational Interviewing Sessions)

Timeframe: Following 3 weeks of motivational interviewing sessions

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

Timeframe: at 12 months post-intervention

Preliminary Efficacy of the LEF-SCP (Symptom Burden)

Timeframe: at 12 months post-intervention

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

Timeframe: at 12 months post-intervention