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

NCT03983083 | Unknown

• 1 other identifier: HEALED_CPS3
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed pilot study will test the acceptability, feasibility, and safety of a twelve-week, 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 a 5-year survival (at Stage I and II) of at least 65% 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, 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. New materials will be disseminated monthly 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. This intervention will add to the very minimal evidence base for PA interventions for diverse cancer survivors in a cost-effective manner.

Conditions

Cancer; Quality of Life; Fatigue

Keywords

physical activity; sedentary behavior

Outcome Measures

Primary Outcomes (3)

• System Usability Scale

  Assesses usability of the HEALED intervention website. 5-point Likert scale strongly disagree to strongly agree. The participant's scores for each question are converted to numbers 0-4, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.

  12 weeks

• Physical activity

  Objectively-measured moderate-vigorous physical activity, light physical activity, and sedentary time

  12 weeks

• Number of exercise-related adverse events (self-reported musculoskeletal injuries, falls, etc.)

  Safety of HEALED intervention

  12 weeks

Secondary Outcomes (3)

• Fatigue Symptom Inventory

  12 weeks

• PROMIS Sleep Disturbance (short form 6a)

  12 weeks

• University of Minnesota Cognitive Function Survey

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Aspects of the HEALED intervention are based on various components of successful interventions for breast cancer survivors and older adults, NCI funding priorities, CPS-3 survivor preferences discussed in prior focus groups and survivorship research from other cohorts. As such, HEALED participants will receive monthly motivational e-mails, based on prior studies of the most effective delivery time intervals for interventions involving cancer survivors, with links to a web-based platform which will provide: physical activity information (largely consisting of publicly available evidence-based resources), at-home exercise demonstrations/videos for survivors of all fitness levels, personal survivor stories, physical activity/sitting recommendations (based on National Guidelines and ACS guidelines for survivors), positive messaging, a space for SMART goal setting, a platform for physical activity tracking, a discussion board, etc.

Behavioral: Physical activity

Wait-list control

NO INTERVENTION

Wait-listed control group will be instructed to continue behavior "as-usual". They will receive access to the HEALED website at the end of the 12-week intervention period.

Interventions

Physical activity BEHAVIORAL

Access to website created to teach cancer survivors to live more active lives, with monthly email reminders/website updates. Intervention participants will also receive exercise bands for at-home resistance training.

Intervention

Eligibility Criteria

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

You may qualify if:

• Response to 2018 CPS-3 English survey
• Stage I or II pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer
• E-mail address on record
• Less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey

You may not qualify if:

• Not community-dwelling
• Unable to walk
• Currently undergoing treatment for a cancer recurrence
• "Yes" response to PAR-Q items

Sponsors & Collaborators

• American Cancer Society, Inc.: lead

Study Sites (1)

American Cancer Society

Atlanta, Georgia, 30303, United States

Location

Related 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.

  PMID: 33954891 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue; Motor Activity; Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Fellow

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 12, 2019
• Study Start: May 15, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)