Health and Energy Through Active Living Every Day After Cancer Intervention for Cancer Survivors

NCT05356988 | Completed DMC

• 1 other identifier: CPS3HEALED
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Cognitive Decline; Fatigue; Sleep; Anxiety; Depression

Keywords

cancer; physical activity; sedentary behavior

Outcome Measures

Primary Outcomes (2)

• Sedentary time

  Device-measured sedentary time with research-grade accelerometer

  12 months

• Physical activity

  Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.

  12 months

Secondary Outcomes (7)

• PROMIS Sleep Disturbance

  12 months

• CPS-3 Fatigue Questions

  12 months

• PROMIS Global Mental and Physical Health

  12 months

• Emotional Distress-Anxiety

  12 months

• Emotional Distress-Depression

  12 months

Study Arms (2)

Physical Activity Group

EXPERIMENTAL

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

Balance and Flexibility Group

ACTIVE COMPARATOR

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

Interventions

Physical activity experiment BEHAVIORAL

The Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities.

Physical Activity Group

Balance and flexibility control BEHAVIORAL

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.

Balance and Flexibility Group

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are a survivor of Stage I - III breast, colon, endometrium, kidney, or bladder cancer, or of multiple myeloma (verified through medical record abstraction/tumor tissue or state registry, to which participants have already consented)
• Are a part of the CPS-3 Portal (this also implies that an email address is on file and an English survey response)
• Must have a physical, continental US street address where they can receive shipments for 12 months.
• Have access to a working smartphone or tablet
• Are not currently pregnant
• Exercise less 300 minutes per week
• Did not register for HEALED Study pilot (n = 99; conducted in 2019, published in 2021; Appendix 11, AM12\_IRB00059007 approved in February 2019)
• Are able to walk assisted

You may not qualify if:

• A doctor has recommended that they avoid moderate or vigorous exercise, or limit walking
• Have received any of the following treatments for their cancer diagnosis in the last 6 months: Surgery to remove the cancer, chemotherapy, radiation therapy, or immunotherapy.
• Have major planned surgery in the next 12 months

Sponsors & Collaborators

• American Cancer Society, Inc.: lead

Study Sites (1)

American Cancer Society (virtual recruitment and study)

Kennesaw, Georgia, 30144, United States

Location

Related Publications (2)

• Rees-Punia E, Leach CR, Westmaas JL, Dempsey LF, Roberts AM, Nocera JR, Patel AV. Pilot Randomized Controlled Trial of Feasibility, Acceptability, and Preliminary Efficacy of a Web-Based Physical Activity and Sedentary Time Intervention for Survivors of Physical Inactivity-Related Cancers. Int J Behav Med. 2022 Apr;29(2):220-229. doi: 10.1007/s12529-021-09999-5. Epub 2021 May 6.

  PMID: 33954891 BACKGROUND

• Rees-Punia E, Masters M, Whalen S, Hartman SJ, Sullivan K, Westmaas JL, Teras LR, Patel AV. Digital intervention for increasing physical activity and reducing sedentary behaviour in cancer survivors: a trial within the Cancer Prevention Study-3 cohort. Br J Sports Med. 2025 Jul 31;59(16):1143-1150. doi: 10.1136/bjsports-2024-109332.

  PMID: 40461052 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Fatigue; Anxiety Disorders; Depression; Neoplasms; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigator will not be involved in randomization, but given the obvious differences in treatment vs. control, participants, investigator, and assessors will be aware of assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will have access for one year to a website to help increase aerobic and strength training activities. The control group will have access for one year to a website to help improve balance and flexibility. At the end of the one-year study, each group will get access to the opposite website.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: June 1, 2022
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: January 11, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)