Personalized exercise program for managing symptoms in head and neck cancer patients

A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain After Head and Neck Cancer Treatment

This study is testing a personalized exercise program using fun video games to help head and neck cancer patients feel less tired and in less pain during their recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy, radiation
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04632654 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a personalized physical activity intervention called PAfitME, which utilizes fitness graded motion exergames to help head and neck cancer patients manage fatigue and musculoskeletal pain during the first six months post-treatment. The intervention combines telehealth support through FaceTime calls and home visits, using platforms like Nintendo Switch to engage patients in physical activity. The study aims to compare the effects of PAfitME against an attention control group, focusing on improvements in fatigue, pain, functional status, and quality of life. Additionally, it will explore factors such as physical activity self-efficacy and enjoyment as potential mediators of the intervention's effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with head and neck cancer and experience moderate fatigue or pain.

Not a fit: Patients who are hospitalized, in hospice care, or have cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life and functional status of head and neck cancer survivors by reducing fatigue and pain.

How similar studies have performed: Previous studies have shown that physical activity can improve symptoms in cancer patients, suggesting that this approach may be effective, although the specific use of motion exergames in this context is relatively novel.

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).

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Hsiao-Lan Wang, Ph.D. — University of Alabama at Birmingham
• Study coordinator: Hsiao-Lan Wang

Conditions Head and Neck Cancer