A Motion Exergaming Approach for Symptom Management: HNC

NCT04632654 | Recruiting DMC

• 2 other identifiers: STUDY0000621R01CA244947-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  Baseline and Week 6

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

  Baseline and Week 6

• Objective Functional Status will be measured by combined grip sum.

  Week 0 and Week 6

• Objective Functional Status will be measured by upper extremity range of motion (ROM).

  Week 0 and Week 6

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

  Week 0 and Week 6

Study Arms (2)

PAfitME

EXPERIMENTAL

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

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).

Interventions

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

PAfitME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for this study, patients must be:
• diagnosed with head and neck cancer (Tumor sites in the head and neck area);
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Hsiao-Lan Wang, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-Lan Wang

CONTACT

317-658-2275; hw3@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 17, 2020
• Study Start: August 21, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)