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

10 giugno 2019 aggiornato da: Erika Rees-Punia, American Cancer Society, Inc.

Health and Energy Through Active Living Every Day After Cancer: The HEALED Pilot Intervention for Cancer Survivors in CPS-3

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.

Panoramica dello studio

Stato

Sconosciuto

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

98

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30303
        • American Cancer Society

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
System Usability Scale
Lasso di tempo: 12 weeks

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
Lasso di tempo: 12 weeks
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.)
Lasso di tempo: 12 weeks
Safety of HEALED intervention
12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fatigue Symptom Inventory
Lasso di tempo: 12 weeks
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.
12 weeks
PROMIS Sleep Disturbance (short form 6a)
Lasso di tempo: 12 weeks
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.
12 weeks
University of Minnesota Cognitive Function Survey
Lasso di tempo: 12 weeks
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).
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2019

Completamento primario (Anticipato)

1 ottobre 2019

Completamento dello studio (Anticipato)

1 ottobre 2019

Date di iscrizione allo studio

Primo inviato

5 giugno 2019

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2019

Primo Inserito (Effettivo)

12 giugno 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HEALED_CPS3

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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