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

Depression Clinical Trial

— HEALED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356988
• Other study ID #: CPS3HEALED
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 24, 2023

Study information

• Verified date: February 2023
• Source: American Cancer Society, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cognitive Decline
• Cognitive Dysfunction
• Depression
• Fatigue
• Quality of Life
• Sleep

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	American Cancer Society (virtual recruitment and study)	Kennesaw	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum In: Int J Behav Med. 2023 Apr;30(2):304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedentary time	Device-measured sedentary time with research-grade accelerometer	12 months
Primary	Physical activity	Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit.	12 months
Secondary	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.	12 months
Secondary	CPS-3 Fatigue Questions	A 5-item Likert scale measuring fatigue, lack of energy and general tiredness within the past month.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	30 second sit-stand test	Video-administered, self-reported sit-stand test (validity study: https://pubmed.ncbi.nlm.nih.gov/34797895/)	12 months