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

Award Number: R01CA244947
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/13/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $680,843 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	6	11/19/2024	NON-COMPETING CONTINUATION	$510,635
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	6	6/11/2025	NON-COMPETING CONTINUATION	$56,736
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	003	6	6/11/2025	NON-COMPETING CONTINUATION	$56,736
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	004	6	9/22/2025	NON-COMPETING CONTINUATION	$0
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	002	6	6/11/2025	NON-COMPETING CONTINUATION	$56,736
														Subtotal = $680,843

Issue Date FY: 2024 ( Subtotal = $553,729 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	002	5	4/15/2024	NON-COMPETING CONTINUATION	$29,110
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	5	11/3/2023	NON-COMPETING CONTINUATION	$523,966
2024	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	4	10/26/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$653
														Subtotal = $553,729

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	4	7/3/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $592,986 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	002	4	6/14/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$592,985
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	001	3	6/14/2022	NON-COMPETING CONTINUATION	-$528,686
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	000	3	11/24/2021	NON-COMPETING CONTINUATION	$528,687
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	005	4	7/5/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$143,852
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	004	3	7/5/2022	NON-COMPETING CONTINUATION	-$1
2022	2021	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	003	2	7/5/2022	NON-COMPETING CONTINUATION	-$143,851
														Subtotal = $592,986

Issue Date FY: 2021 ( Subtotal = $581,576 )
2021	2021	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	000	2	12/1/2020	NON-COMPETING CONTINUATION	$552,749
2021	2021	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	001	2	1/28/2021	NON-COMPETING CONTINUATION	$28,827
														Subtotal = $581,576

Issue Date FY: 2020 ( Subtotal = $616,239 )
2020	2020	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	001	1	1/27/2020	NEW	$14,254
2020	2020	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Treatment Research	000	1	12/13/2019	NEW	$601,985
														Subtotal = $616,239

Grand Total All Awards = $3,025,373

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

Award Number: R01CA244947

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/13/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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