Physical activity experiment for Fatigue

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
American Cancer Society (virtual recruitment and study), Kennesaw, GA
Fatigue+6 More
Physical activity experiment - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Fatigue
  • Quality of Life (QOL)
  • Depression
  • Cognitive Decline
  • Sleep
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 12 months

12 months
30 second sit-stand test
CPS-3 Fatigue Questions
Emotional Distress-Anxiety
Emotional Distress-Depression
PROMIS Cognitive Function
PROMIS Global Mental and Physical Health
PROMIS Sleep Disturbance
Physical activity
Sedentary time

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Balance and Flexibility Group
1 of 2
Physical Activity Group
1 of 2
Active Control
Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: Physical activity experiment · No Placebo Group · N/A

Physical Activity Group
Behavioral
Experimental Group · 1 Intervention: Physical activity experiment · Intervention Types: Behavioral
Balance and Flexibility Group
Behavioral
ActiveComparator Group · 1 Intervention: Balance and flexibility control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: American Cancer Society (virtual recruitment and study) · Kennesaw, GA
Photo of georgia 1Photo of georgia 2Photo of georgia 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Fatigue
0 CompletedClinical Trials

Who is running the clinical trial?

American Cancer Society, Inc.Lead Sponsor
210 Previous Clinical Trials
97,863 Total Patients Enrolled
5 Trials studying Fatigue
339 Patients Enrolled for Fatigue

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a part of the CPS-3 Portal.
You must have a physical, continental US street address where you can receive shipments for 12 months.
You have access to a smartphone or tablet.
You are able to walk assisted.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.