Head and Neck CancerNCT04632654
A Motion Exergaming Approach for Symptom Management: HNC
A study testing A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) in people with Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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%;
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Kelly Brown, brownkl@uab.edu
About this study
Official title: A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment
This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Nintendo Switch). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data.
Read the detailed description
Among head and neck cancer (HNC) patients, 92% report fatigue and 73% have pain. A 10% increase in fatigue or pain is associated with a 10-25% reduction in HNC survival. During the critical transition period from the end of active treatment to 6 months post-treatment, untreated physical symptoms negatively impact functional status (ADL) and quality of life (QOL). Fatigue and musculoskeletal pain are known to improve in response to physical activity (PA). However, 51% of HNC survivors rarely engage in any type of PA because of complicated PA barriers. Our overall objective is to test an intervention to overcome these PA barriers for HNC patients during the critical transition period to self-management. PAfitME, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principle of adaptation. PAfitME, delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Wii Fit and Xbox Kinect). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed-effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data. This study aligns with the NCI Cancer Moonshot goal to minimize cancer treatment-associated side effects and the key recommendation in the National Comprehensive Cancer Network Clinical Guidelines of the need for evidence-based non- pharmacological fatigue/pain treatments (National Priority).
- Conditions
- Head and Neck Cancer
- Being tested
- A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAfitME | Experimental | For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention. Receives: Behavioral: A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) |
| Attention Control | No intervention | For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).
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.
Measured: Baseline and Week 6
Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).
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.
Measured: Baseline and Week 6
Secondary outcomes (7)
Subjective Functional Status will be measured by the self-report Lawton Instrumental Activities of Daily Living Scale (IADL).
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.
Measured: Baseline and Week 6
Objective Functional Status will be measured by 2-minute walk test.
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.
Measured: Baseline and Week 6
Objective Functional Status will be measured by combined grip sum.
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.
Measured: Week 0 and Week 6
Objective Functional Status will be measured by upper extremity range of motion (ROM).
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.
Measured: Week 0 and Week 6
Objective Functional Status will be measured by chair sit and reach.
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.
Measured: Week 0 and Week 6
Objective Functional Status will be measured by Timed up and go.
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.
Measured: Week 0 and Week 6
Quality of Life will be measured using the Functional Assessment of Chronic Illness Therapy-Head and Neck Scale, version 4 (FACIT-H&N).
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.
Measured: Week 0 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start21 Aug 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hsiao-Lan Wang, University of Alabama at Birmingham
- Investigators
- Hsiao-Lan Wang, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632654
- Sponsor's protocol ID
- STUDY000062
- Other IDs
- 1R01CA244947-01
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment
- ClinicalTrials.gov ID
- NCT04632654
- Acronym / sponsor ID
- STUDY000062
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Nintendo Switch). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data.
Detailed description
Among head and neck cancer (HNC) patients, 92% report fatigue and 73% have pain. A 10% increase in fatigue or pain is associated with a 10-25% reduction in HNC survival. During the critical transition period from the end of active treatment to 6 months post-treatment, untreated physical symptoms negatively impact functional status (ADL) and quality of life (QOL). Fatigue and musculoskeletal pain are known to improve in response to physical activity (PA). However, 51% of HNC survivors rarely engage in any type of PA because of complicated PA barriers. Our overall objective is to test an intervention to overcome these PA barriers for HNC patients during the critical transition period to self-management. PAfitME, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principle of adaptation. PAfitME, delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Wii Fit and Xbox Kinect). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed-effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data. This study aligns with the NCI Cancer Moonshot goal to minimize cancer treatment-associated side effects and the key recommendation in the National Comprehensive Cancer Network Clinical Guidelines of the need for evidence-based non- pharmacological fatigue/pain treatments (National Priority).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAfitME | Experimental | Behavioral: A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention. |
| Attention Control | No intervention | –For 6 weeks, the attention control group will receive National Cancer Institute-based survivorship education and exergame equipment (Nintendo Switch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%;
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)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. | Behavioural | PAfitME |
Primary outcome
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
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.
Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).
Time frame: Baseline and Week 6
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.
7 secondary outcomes
Subjective Functional Status will be measured by the self-report Lawton Instrumental Activities of Daily Living Scale (IADL).
Time frame: Baseline and Week 6
Objective Functional Status will be measured by 2-minute walk test.
Time frame: Baseline and Week 6
Objective Functional Status will be measured by combined grip sum.
Time frame: Week 0 and Week 6
Objective Functional Status will be measured by upper extremity range of motion (ROM).
Time frame: Week 0 and Week 6
Objective Functional Status will be measured by chair sit and reach.
Time frame: Week 0 and Week 6
Objective Functional Status will be measured by Timed up and go.
Time frame: Week 0 and Week 6
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hsiao-Lan Wang, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) in people with Head and Neck Cancer, run by University of Alabama at Birmingham 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Lan Wang (317-658-2275, hw3@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.