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Health and Energy Through Active Living Every Day (HEALED) After Cancer Pilot Intervention for Cancer Survivors
Health and Energy Through Active Living Every Day After Cancer: The HEALED Pilot Intervention for Cancer Survivors in CPS-3
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The Health and Energy through Active Living Every Day (HEALED) after cancer pilot study is a randomized consent, parallel assignment twelve-week physical activity behavioral intervention. HEALED is intended for survivors of a cancer with a 5-year survival (at Stage I and II) of at least 65% that is categorized as having a strong level of evidence for association with physical inactivity according to the 2018 Physical Activity Guidelines Advisory Committee Report, which includes: breast, colon, endometrium, kidney, and bladder.(11) HEALED has a two-arm design, including an experimental group (n=50) and a wait-listed control group (n=50) which will be instructed to continue behavior "as-usual".
Participants will be recruited through the Cancer Prevention Study-3 (CPS-3). CPS-3 is a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society (ACS). Over 254,000 CPS-3 participants aged 30 to 65 years with no history of cancer (except for basal or squamous cell skin cancer) completed a baseline survey at enrollment and are sent repeat surveys every three years to update exposure information.(17) All CPS-3 participants will be followed up for cancer incidence and mortality from any cause for at least 20 years. Between enrollment and 2015, there were over 6100 cancer cases in the CPS-3 cohort.
Eligibility for HEALED will be determined based on existing data from CPS-3 2015 and 2018 surveys. Inclusion criteria require: 1) response to 2018 CPS-3 English survey, 2) a self-reported pre- or postmenopausal breast, colon, endometrium, kidney, or bladder cancer, 3) an e-mail address on record, and 4) less than 150 minutes MVPA/week and/or no strength training reported on 2018 survey. Participants will be excluded if they: 1) are not community-dwelling, 2) are not able to walk, or 3) are currently undergoing treatment for a cancer recurrence.
Participants will be invited via email. Based on the CPS-3 physical activity sub-study, in which participants were required to wear an accelerometer for two seven-day periods and complete four seven-day diaries over a one-year period, a 20% response rate is expected. Interested participants will complete a short online screener questionnaire and provide online consent if eligible. The screening questionnaire will include items regarding stage at diagnosis and recurrence, and a physical activity readiness questionnaire (PAR-Q). Participants responding 'yes' to one or more of any of the following items will be excluded from the HEALED intervention to rule-out survivors for whom unsupervised physical activity may be unsafe: a) Has your doctor ever said that you have a heart condition and that you should only perform physical activity recommended by a doctor?, b) Do you lose your balance because of dizziness or do you ever lose consciousness?, c) Do you have a bone or joint problem that could be made worse by a change in your physical activity?, or d) Do you know of any other reason why you should not engage in physical activity? Once an eligible participant provides consent, they will be sent an accelerometer (including instructions for wear and return shipping materials) along with a 4-page survey.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- American Cancer Society
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not community-dwelling
- Unable to walk
- Currently undergoing treatment for a cancer recurrence
- "Yes" response to PAR-Q items
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention
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.
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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.
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Geen tussenkomst: Wait-list control
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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System Usability Scale
Tijdsspanne: 12 weeks
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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
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Physical activity
Tijdsspanne: 12 weeks
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Objectively-measured moderate-vigorous physical activity, light physical activity, and sedentary time
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12 weeks
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Number of exercise-related adverse events (self-reported musculoskeletal injuries, falls, etc.)
Tijdsspanne: 12 weeks
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Safety of HEALED intervention
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Fatigue Symptom Inventory
Tijdsspanne: 12 weeks
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Physical and mental fatigue, 14 items.
Items use an 11-point, Likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue).
A global score can be obtained for items 1-13.
Question 14 is meant to provide qualitative data only.
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12 weeks
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PROMIS Sleep Disturbance (short form 6a)
Tijdsspanne: 12 weeks
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Sleep disturbances and overall sleep quality, 6 items.
Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 6 to 30 with higher scores indicating greater severity of sleep disturbance.
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12 weeks
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University of Minnesota Cognitive Function Survey
Tijdsspanne: 12 weeks
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Survey-assessed cognitive function from the Long-Term Follow-Up Study.
25 items with three-point Likert-type scale ranging from "Never a problem" to "Often a problem".
Scores range from 25-75, with scores above 50 indicating issues with cognitive function (largely problem-solving).
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12 weeks
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HEALED_CPS3
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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