Quality of LifeHEALEDNCT05356988
Health and Energy Through Active Living Every Day After Cancer Intervention for Cancer Survivors
A study testing Physical activity experiment in people with Quality of Life and Cognitive Decline, run by American Cancer Society, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Cognitive Decline, Fatigue
- What is being tested?
- Physical activity experiment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 24 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
American Cancer Society (virtual recruitment and study)
Kennesaw, Georgia, 30144
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Cognitive Decline, Fatigue, Sleep, Anxiety, Depression
- Being tested
- Physical activity experiment, Balance and flexibility control
- Keywords
- cancer, physical activity, sedentary behavior
- Medical subject headings
- Cognitive Dysfunction, Fatigue, Anxiety Disorders, Depression, Neoplasms, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity experimentBehavioural
The Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities.
Balance and flexibility controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Balance and flexibility control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary time
Device-measured sedentary time with research-grade accelerometer
Measured: 12 months
Physical activity
Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 12 months
CPS-3 Fatigue Questions
A 5-item Likert scale measuring fatigue, lack of energy and general tiredness within the past month.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
30 second sit-stand test
Video-administered, self-reported sit-stand test (validity study: https://pubmed.ncbi.nlm.nih.gov/34797895/)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jun 2022
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Cancer Society, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356988
- Sponsor's protocol ID
- CPS3HEALED
- Acronym
- HEALED
- Status last verified
- Feb 2023
- First submitted
- 27 Apr 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33954891Chiang KE, Masters M, Whalen S, Donzella S, Bates-Fraser LC, Peoples AR, Zhong C, Sullivan K, Hartman SJ, Patel AV, Rees-Punia E. The Impact of a Physical Activity Intervention on Cognitive and Mental Health Outcomes in Cancer Survivors. Psychooncology. 2026 Aug;35(8):e70588. doi: 10.1002/pon.70588.
PubMed 42640227Rees-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.
PubMed 40461052
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Energy Through Active Living Every Day After Cancer Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT05356988
- Acronym / sponsor ID
- HEALED / CPS3HEALED
- Conditions
- Quality of Life, Cognitive Decline, Fatigue, Sleep, Anxiety, Depression
- Keywords
- cancer, physical activity, sedentary behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- American Cancer Society, Inc.University, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Group | Experimental | Behavioral: Physical activity experimentPhysical 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. |
| Balance and Flexibility Group | Active comparator | Behavioral: Balance and flexibility controlThe 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. |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity experimentThe Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities. | Behavioural | Physical Activity Group |
| Balance and flexibility controlThe static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure around stretching and balance exercises. | Behavioural | Balance and Flexibility Group |
Primary outcome
Sedentary time
Time frame: 12 months
Device-measured sedentary time with research-grade accelerometer
Physical activity
Time frame: 12 months
Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.
7 secondary outcomes
PROMIS Sleep Disturbance
Time frame: 12 months
CPS-3 Fatigue Questions
Time frame: 12 months
PROMIS Global Mental and Physical Health
Time frame: 12 months
Emotional Distress-Anxiety
Time frame: 12 months
Emotional Distress-Depression
Time frame: 12 months
PROMIS Cognitive Function
Time frame: 12 months
30 second sit-stand test
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 33954891Rees-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.
- Derived from this study: PubMed 42640227Chiang KE, Masters M, Whalen S, Donzella S, Bates-Fraser LC, Peoples AR, Zhong C, Sullivan K, Hartman SJ, Patel AV, Rees-Punia E. The Impact of a Physical Activity Intervention on Cognitive and Mental Health Outcomes in Cancer Survivors. Psychooncology. 2026 Aug;35(8):e70588. doi: 10.1002/pon.70588.
- Derived from this study: PubMed 40461052Rees-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity experiment in people with Quality of Life and Cognitive Decline, run by American Cancer Society, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356988, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.