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Exergaming for Head and Neck Cancer

N/A

Recruiting

Led By Hsiao-Lan Wang, Ph.D.

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to communicate

Patients must be 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 and week 6

Awards & highlights

Study Summary

This trial is testing an intervention to help head and neck cancer patients overcome barriers to physical activity during the first 6 months after their treatment. The intervention includes FaceTime calls and home visits, and uses commercially available exergaming platforms (Nintendo Switch). The trial will compare the experimental group receiving the intervention to an attention control group, and will evaluate the effect of the intervention on fatigue, musculoskeletal pain, functional status, and quality of life.

Who is the study for?

This trial is for adults over 18 with head and neck cancer who can understand English, communicate well, and have a moderate ability to perform daily activities (KPS score >=60%). They must be cleared for low to moderate physical activity by their doctor and experience at least moderate fatigue or pain. Those with cognitive impairments, hospitalization, hospice care, or seizure history are excluded.Check my eligibility

What is being tested?

The study tests PAfitME—a personalized exercise program using motion exergames like Nintendo Switch—against standard survivorship education. It aims to see if PAfitME reduces fatigue and pain while improving functional status and quality of life in post-treatment head and neck cancer patients over six weeks.See study design

What are the potential side effects?

Since the intervention involves physical activity through exergaming, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can communicate effectively.

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I am 18 years old or older.

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I have been diagnosed with cancer in my head or neck area.

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I experience moderate to severe fatigue or pain.

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I have experienced moderate fatigue or pain, rating it 4 or higher in the past week.

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I am mostly able to care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).

Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).

Secondary outcome measures

Objective Functional Status will be measured by 2-minute walk test.

Objective Functional Status will be measured by Timed up and go.

Objective Functional Status will be measured by chair sit and reach.

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PAfitMEExperimental Treatment1 Intervention

For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention.

Group II: Attention ControlActive Control1 Intervention

For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

410 Previous Clinical Trials

186,758 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,589 Previous Clinical Trials

2,280,204 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,923 Total Patients Enrolled

Media Library

A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) Clinical Trial Eligibility Overview. Trial Name: NCT04632654 — N/A

Head and Neck Cancers Research Study Groups: Attention Control, PAfitME

Head and Neck Cancers Clinical Trial 2023: A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) Highlights & Side Effects. Trial Name: NCT04632654 — N/A

A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632654 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is this research involving participants?

"Affirmative. According to clinicaltrials.gov, this medical experiment - first published on August 21st 2020 - is currently recruiting participants. The study requires 150 patients from a single site for completion."

Answered by AI

What are the principal aims of this experiment?

"The primary assessment of this study at Baseline and Week 6 is determining the level of Fatigue, which will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]). As secondary objectives, Objective Functional Status will be measured by upper extremity range of motion (ROM), Timed up and go test, as well as Quality of Life via a Functional Assessment of Chronic Illness Therapy-Head and Neck Scale, version 4 (FACIT-H&N)."

Answered by AI

Are there any chances to join this research effort right now?

"According to the details posted on clinicaltrials.gov, this experiment is still gathering participants; it was first made available on August 21st 2020 and its information has been refreshed as recently as June 13th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Motion Exergaming Approach for Symptom Management: HNC

Hsiao-Lan Wang 2020. "A Motion Exergaming Approach for Symptom Management: HNC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04632654.