- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632654
A Motion Exergaming Approach for Symptom Management: HNC
A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hsiao-Lan Wang
- Phone Number: 317-658-2275
- Email: hw3@uab.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Kelly Brown
- Email: brownkl@uab.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
To be eligible for this study, patients must be:
- diagnosed with head and neck cancer (Tumor sites in the head and neck area);
- 18 years or older;
- able to understand English;
- able to communicate;
- have a Karnofsky Performance Status (KPS) score of >= 60%;
- be cleared by their provider to resume low to moderate intensity PA;
- have fatigue or pain of ≥moderate severity; and
A KPS score of >= 60% has been used in previous exercise trials in the HNC population. This is equal to ECog scores ≤ 2.
Moderate fatigue or pain severity is defined as a worst score in the past week of >= 4 on a 0-10 scale.
Patients receiving immunotherapy are not excluded from participating in the study.
Exclusion Criteria:
Patients will be excluded if they
- are hospitalized;
- are in hospice care;
- have a history of seizures or loss of consciousness; or
- are cognitively impaired, defined as making ≥3 errors on a validated 6-item cognitive screener (3 items identifying the current year, month, and day; 3 items recalling 3 pre-selected objects).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PAfitME
For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention.
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A total of 7 weekly intervention sessions will occur in a period of 6 weeks.
Week 0 is a setup session conducted at the participant's home, including equipment set up, safety instruction, personalized exergame prescription development, exergame physical activity practice, discussion of barriers and strategies, and Q&A session.
Weeks 1 and 2 are coaching sessions delivered by the interventionist using the FaceTime application in iPad, including exergame minutes and prescription review, exergame physical activity practice, discussion of barriers and strategies, and Q&A session.
Week 3 is a progress session conducted at the participant's home.
The personalized exergame prescription will be adjusted.
This session also will include exergame minutes review, exergame physical activity practice, discussion of barriers and strategies, and Q&A session.
Weeks 4 and 5 are the same as weeks 1 and 2. Week 6 is the final session.
Exergame platform will be picked up at the participant's home.
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No Intervention: Attention Control
For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).
Time Frame: Baseline and Week 6
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In the PROMIS Short Form v1.0-Fatigue, the 6 items ask about fatigue status, including fatigue severity and fatigue distress in the past 7 days.
The scale ranges from 1 to 5. The higher the score, the worse the symptom.
The mean score of 6 items will be calculated in the analysis to test the changes from baseline to week 6.
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Baseline and Week 6
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Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).
Time Frame: Baseline and Week 6
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In the PROMIS Short Form v1.0-Pain, the 3 items ask about pain intensity in the past 7 days.
The scale ranges from 1 to 5. The higher the score, the worse the symptom.
The mean score of 3 items will be calculated in the analysis to test the changes from baseline to week 6.
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Baseline and Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Functional Status will be measured by the self-report Lawton Instrumental Activities of Daily Living Scale (IADL).
Time Frame: Baseline and Week 6
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In the IADL, the 8-item IADL measures dependence/independence of 8 daily activities.
Participants will respond based on their highest level of independence for that activity.
The total score ranges from 8 to 31.
The higher the score, the better the function.
The toal score of 8 items will be calculated in the analysis to test the changes from baseline to week 6.
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Baseline and Week 6
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Objective Functional Status will be measured by 2-minute walk test.
Time Frame: Baseline and Week 6
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The 2-minute walk measures distance (in meters) walked in 2 minutes.
The distance in meters will will be calculated in the analysis to test the changes from baseline to week 6.
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Baseline and Week 6
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Objective Functional Status will be measured by combined grip sum.
Time Frame: Week 0 and Week 6
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Combined grip sum is calculated by "[left hand grip strength maximum + right hand grip strength maximum] ÷ body weight".
It levels out the dominant hand effect (by using the sum of left hand and right hand strength) and represents the ratio of hand muscle strength and body weight.
Hand grip strength will be measured by Jamar hydraulic hand dynamometer (Jamar Technologies, Inc., Hatfield, PA).The combined grip sum will be calculated in the analysis to test the changes from baseline to week 6.
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Week 0 and Week 6
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Objective Functional Status will be measured by upper extremity range of motion (ROM).
Time Frame: Week 0 and Week 6
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Upper extremity ROM is upper extremity flexibility and includes shoulder abduction, shoulder forward flexion, neck forward flexion, neck extension, neck lateral flexion, and neck lateral rotation.
The ROM will be measured by a plastic 12" goniometer 360 degree (Szy Holdings LLC, Brooklyn, NY).
The degrees of range of motion will be calculated in the analysis to test the changes from baseline to week 6.
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Week 0 and Week 6
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Objective Functional Status will be measured by chair sit and reach.
Time Frame: Week 0 and Week 6
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Chair sit and reach is to measure lower extremity flexibility.
The participant sits on a chair with one foot flat on the floor to support the balance and the other leg extended forward with knee straight, heel on the floor, and ankle bent at 90º.
With one hand on top of the other, the participant reaches forward toward the toes by bending at the hip.
The distance between the tip of the fingertips and the toes is measured.
If the fingertips touch the toes, the score is zero.
If they do not touch, the distance between the fingers and the toes (a negative score) is measured; if they overlap, the overlap distance is measured (a positive score).
The distance in positive or negative centImeters (cm) will be calculated in the analysis to test the changes from baseline to week 6.
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Week 0 and Week 6
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Objective Functional Status will be measured by Timed up and go.
Time Frame: Week 0 and Week 6
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Timed up and go requires participants to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
The result of the test is the time from standing up from the chair to sitting back on the same chair.
The time in seconds will be calculated in the analysis to test the changes from baseline to week 6.
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Week 0 and Week 6
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Quality of Life will be measured using the Functional Assessment of Chronic Illness Therapy-Head and Neck Scale, version 4 (FACIT-H&N).
Time Frame: Week 0 and Week 6
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FACIT-H&N includes a 28-item general scale and a 12-item HNC scale.
The scale ranges from 0 to 4. The greater the score, the better the quality of life.
The mean scores of the 28-item general scale and 12-item HNC scale will be calculated in the analysis to test the changes from baseline to week 6.
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Week 0 and Week 6
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hsiao-Lan Wang, Ph.D., University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY000062
- 1R01CA244947-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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