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Principal Investigator: Hsiao-Lan Wang
Organization: UNIVERSITY OF ALABAMA AT BIRMINGHAM
Fiscal Year: 2024
Award: $553,076
Funding agency: National Cancer Institute
Project Summary/Abstract
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 3 months post-treatment (during which patients begin symptom self-
management), untreated physical symptoms negatively impact functional status (ADL) and quality of life
(QOL). Fatigue and musculoskeletal pain (related to tissue damage from surgery and radiation) 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: impaired fitness, severe physical symptoms, and poor PA health beliefs.
A critical gap in our science is that no home-based behavioral PA intervention effectively addresses these PA
barriers in HNC patients. To address this gap, 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 principal of adaptation. PAfitME is personalized to the HNC patient's PA
barriers. PAfitME, delivered via a tested mix of FaceTime calls and home visits, uses commercially available
exergaming platforms (Wii Fit and Xbox Kinect). Our pilot study generated impressive within-group effect sizes
for fatigue, pain, and ADL (d≥0.9). The feasibility and acceptability of PAfitME were also strong in patients with
several physical limitations. Attendance (98%) and attrition (20%) were much better than previous HNC studies
without adverse events. 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 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 (Wii Fit or Xbox Kinect without
PAfitME). For Aims 1 and 2, using an ITT 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).
Terms: <Address><Adverse Experience><Adverse event><After Care><After-Treatment><Aftercare><Age><Articular Range of Motion><Behavior><Behavioral><Body Tissues><Cancer Patient><Cancer Survivor><Cancer Survivorship><Cancer Treatment><Cancers><Chronic Disease><Chronic Illness><Clinical><Competence><Control Groups><Data><Education><Educational aspects><Eligibility><Eligibility Determination><Enrollment><Enteral Feeding><Equipment><Exercise><Fatigue><Future><Goals><Grips><Guidelines><HNC patient><Head and Neck Cancer><Head and Neck Carcinoma><Health><Home><Home visitation><House Call><Iatrogenic Cancer><Impairment><Individual><Intervention><Intervention Strategies><Joint Range of Motion><Lack of Energy><Literature><Long-Term Effects><Longterm Effects><Malignant Head and Neck Neoplasm><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Mediating><Mediation><Membrum superius><Modeling><Motion><Musculoskeletal Pain><NCCN><National Comprehensive Cancer Network><Negotiating><Negotiation><Operative Procedures><Operative Surgical Procedures><Outcome><Pain><Pain Control><Pain Therapy><Pain management><Painful><Participant><Patients><Performance><Phase><Phase 2 Clinical Trials><Phase II Clinical Trials><Physical activity><Pilot Projects><Pre-Post Tests><Protocol Screening><Publishing><QOL><Quality of life><Radiation><Recommendation><Reporting><Research Design><Science><Self Efficacy><Self Management><Series><Skeletal Muscle><Stimulus><Study Type><Sum><Surgical><Surgical Interventions><Surgical Procedure><Symptoms><Technology><Testing><Therapy Related Malignant Neoplasm><Therapy Related Malignant Tumor><Therapy-Associated Cancers><Therapy-Related Cancer><Time><Tissues><Tracheostomy><Tracheostomy procedure><Treatment Period><Treatment-Associated Cancer><Treatment-Related Cancer><Upper Extremity><Upper Limb><Voluntary Muscle><Walking><acceptability and feasibility><active method><active technique><active treatment><ages><anti-cancer therapy><attentional control><cancer survival><cancer therapy><cancer-directed therapy><chemo-/radio-therapy><chemo-radio-therapy><chemo-radiotherapy><chemoradiation><chemoradiation therapy><chemoradiation treatment><chemoradiotherapy><chronic disorder><design><designing><effective intervention><enroll><enteric feeding><evidence base><exercise intervention><exergame><experimental group><feeding tube><fitness><functional adaptation><functional status><gastric feeding><grasp><group intervention><head and neck cancer patient><head/neck cancer><health belief><health-related belief><home visit><homes><improved><innovate><innovation><innovative><interventional strategy><malignancy><malignant head and neck tumor><neoplasm/cancer><pain score><pain treatment><phase II protocol><physical activity intervention><physical symptom><pilot study><post treatment><primary outcome><programs><public health relevance><radio-chemo-therapy><radio-chemotherapy><radiochemotherapy><range of motion><response><secondary outcome><sex><side effect><social cognitive theory><social learning theory><study design><surgery><survivorship><symptom self management><telehealth><treatment days><treatment duration><tube feeding><visual feedback>