Clinical trial NCT05356988: Health and Energy Through Active Living Every Day After Cancer Intervention for Cancer Survivors
Official title: Health and Energy Through Active Living Every Day After Cancer Intervention for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Cognitive Decline
Fatigue
Sleep
Anxiety
Depression
Keywords: cancer
physical activity
sedentary behavior
Lead sponsor: American Cancer Society, Inc.
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 415
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sedentary time
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
Secondary outcomes:
measure: PROMIS Sleep Disturbance
timeFrame: 12 months
measure: CPS-3 Fatigue Questions
timeFrame: 12 months
measure: PROMIS Global Mental and Physical Health
timeFrame: 12 months
measure: Emotional Distress-Anxiety
timeFrame: 12 months
measure: Emotional Distress-Depression
timeFrame: 12 months
measure: PROMIS Cognitive Function
timeFrame: 12 months
measure: 30 second sit-stand test
timeFrame: 12 months
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: American Cancer Society (virtual recruitment and study)
state: Georgia
Study officials:
References:
citation: 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.