An interventional study of Physical activity experiment and Balance and flexibility control in Quality of Life, Cognitive Decline and Fatigue, sponsored by American Cancer Society, Inc.. Completed at 1 site in United States. Open to participants aged 55 Years to 77 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by American Cancer Society, Inc. · Not applicable, Interventional, and Supportive care
The purpose of the Health and Energy through Active Living Every Day (HEALED) intervention, is to examine the effect of a web-based intervention on changes in device-measured physical activity (light and moderate-to-vigorous intensity aerobic) and sedentary behavior. The purpose of this study is intended for survivors of a cancer with a 5-year survival (at Stage I, II, and III) of at least 45% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, bladder, multiple myeloma). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. New materials will be disseminated biweekly through a website open only to participants, and include at-home exercise demonstration videos, research news, discussion boards, success stories, infographics for exercise recommendations, etc.
By 2026, there will be approximately 20.3 million cancer survivors in the U.S., and this population is expected to grow with improved cancer survival rates. Cancer survivors experience a myriad of side effects following treatment, including fatigue, decreased muscle mass, balance issues, decreased cognitive function, and an increased risk of comorbidities. Observational studies and randomized controlled trials suggest that physical activity (PA) is a safe and effective non-pharmacologic option for improving some of these side effects. Despite the evidence, it is estimated that at least 75% of cancer survivors do not meet PA guidelines. Interventions tailored for survivors may increase PA, but there are gaps in the literature regarding the most effective methods. Further, there are several cancers associated with physical inactivity, but most PA interventions focus on breast cancer. Additionally, many existing interventions require in-person meetings, are very resource-intensive, and may not be sustainable. Most physical activity interventions focus on the promotion of moderate-vigorous PA, ignoring the importance of decreased sedentary time and increased light PA. Accordingly, it is imperative to create more sustainable, broad-reaching PA and sedentary behavior interventions that are intended for survivors of various physical inactivity-associated cancers. The proposed one-year study will be a two-arm, randomized control intervention embedded within the Cancer Prevention Study-3 (CPS-3), a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society. The proposed Health and Energy through Active Living Every Day (HEALED) intervention is intended for survivors of a cancer with an expected 5-year survival (at Stage I, II or III) of at least 45% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, multiple myeloma, and bladder). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. Materials and tools will be updated monthly through a secure website open only to participants, and include: at-home exercise demonstration videos, steps leaderboards, goal setting tools, Fitbit self-monitoring and syncing capabilities, discussion boards, success stories, infographics for exercise recommendations, etc. This intervention will add to the very minimal evidence base for PA interventions for diverse cancer survivors in a sustainable, broad-reaching manner. Further, the data resulting from this study will provide insight towards promotion of the "time-use" approach, which focuses on all of the movement behaviors (including sedentary time, light intensity physical activity, and moderate-to-vigorous physical activity), which has not yet been used in interventions for survivors.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 415 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →American Cancer Society, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Physical activity (PA) group participants will receive behavioral nudge e-mails with links to a web-based platform which will provide: physical activity information, at-home exercise demonstrations/videos for survivors of all fitness levels, articles, blog posts, physical activity/sitting recommendations, a space for goal setting, a platform for physical activity tracking, a discussion board, automatic syncing of their Fitbit to the leaderboard, etc.
Behavioral: Physical activity experiment
The static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure. They will receive access to the HEALED website at the end of the 12-month intervention period.
Behavioral: Balance and flexibility control
The Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities.
The static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure around stretching and balance exercises.
Sedentary time
Device-measured sedentary time with research-grade accelerometer
Time frame: 12 months
Physical activity
Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.
Time frame: 12 months
PROMIS Sleep Disturbance
5-item questionnaire measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days.
Time frame: 12 months
CPS-3 Fatigue Questions
A 5-item Likert scale measuring fatigue, lack of energy and general tiredness within the past month.
Time frame: 12 months
PROMIS Global Mental and Physical Health
Instrument consists of ten global health items that represent five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Four items are used to assess global physical health. Four items are used to assess global mental health, all of which are administered using five-category response scales. Higher scores indicate better mental/physical health.
Time frame: 12 months
Emotional Distress-Anxiety
A PROMIS assessment of 8-items on the pure domain of anxiety in individuals age 18 and older. High scores indicate higher anxiety symptom severity.
Time frame: 12 months
Emotional Distress-Depression
A PROMIS assessment of 7-items on the pure domain of depression in individuals age 18 and older. High scores indicate higher depression symptom severity.
Time frame: 12 months
PROMIS Cognitive Function
This item bank assesses patient-perceived cognitive deficits. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. Higher scores indicate higher cognitive funciton.
Time frame: 12 months
30 second sit-stand test
Video-administered, self-reported sit-stand test (validity study: https://pubmed.ncbi.nlm.nih.gov/34797895/)
Time frame: 12 months
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Plan to share: No
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American Cancer Society, Inc.