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

January 9, 2024 updated by: American Cancer Society, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
415

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Kennesaw, Georgia, United States, 30144
        • American Cancer Society (virtual recruitment and study)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical Activity Group
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 Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities.
Active Comparator: Balance and Flexibility Group
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 static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure around stretching and balance exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sedentary time
Time Frame: 12 months
Device-measured sedentary time with research-grade accelerometer
12 months
Physical activity
Time Frame: 12 months
Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Sleep Disturbance
Time Frame: 12 months
5-item questionnaire measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days.
12 months
CPS-3 Fatigue Questions
Time Frame: 12 months
A 5-item Likert scale measuring fatigue, lack of energy and general tiredness within the past month.
12 months
PROMIS Global Mental and Physical Health
Time Frame: 12 months
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.
12 months
Emotional Distress-Anxiety
Time Frame: 12 months
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.
12 months
Emotional Distress-Depression
Time Frame: 12 months
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.
12 months
PROMIS Cognitive Function
Time Frame: 12 months
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.
12 months
30 second sit-stand test
Time Frame: 12 months
Video-administered, self-reported sit-stand test (validity study: https://pubmed.ncbi.nlm.nih.gov/34797895/)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Cancer Society, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPS3HEALED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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