A Motion Exergaming Approach for Symptom Management: HNC

NCT ID: NCT04632654

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-21
• Study Completion Date: 2026-11-30

Brief 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. 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).

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PAfitME

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

Group Type: EXPERIMENTAL

A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)

Intervention Type: BEHAVIORAL

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.

Attention Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

To be eligible for this study, patients must be:

1. diagnosed with head and neck cancer (Tumor sites in the head and neck area);

2. 18 years or older;

3. able to understand English;

4. able to communicate;

5. have a Karnofsky Performance Status (KPS) score of >= 60%;

6. be cleared by their provider to resume low to moderate intensity PA;

7. 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

1. are hospitalized;

2. are in hospice care;

3. have a history of seizures or loss of consciousness; or

4. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Lan Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiao-Lan Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hsiao-Lan Wang

Role: CONTACT

hw3@uab.edu

317-658-2275

Facility Contacts

Kelly Brown

Role: primary

brownkl@uab.edu

Other Identifiers

1R01CA244947-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY000062

Identifier Type: -

Identifier Source: org_study_id