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 range18 Years

SexALL

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

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 range18 Years

SexALL

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