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NCT05349227Toboroz

Comprehensive Outcomes for After Cancer Health

Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. dec. 11. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
625 (tervezett)
Első benyújtás
2022. ápr. 14.
Kezdés
2022. jún. 23.
Elsődleges befejezés
2026. dec.
Fő szponzor
Pack Health
NCT-szám
NCT05349227

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 625
  • 2022. jún. 23. és az elsődleges befejezés (2026. dec.) között
  • 7 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
  • Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
  • Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.
    • Healthy Volunteers must:

Életkor

  • Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.

Egyéb

  • Have a life expectancy of \<6 months, and/or
  • Must reside in the same dwelling as the patient participant
  • Can read and consent to participate in the trial;
  • Can read and speak English;
  • Can complete study follow-up at pre-specified intervals;

Kiket keres a vizsgálat

  • Have primary diagnosis of cancer;
  • Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
    • For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
    • For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).
  • Are aged 18 years and older;
  • Can read and consent to participate in the trial;
  • Can read and speak English;
  • Can complete study follow-up at pre-specified intervals;
  • Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (7)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Dana-Farber Cancer InstituteBostonEgyesült ÁllamokToboroz
The Ohio State University -Wexner Medical CenterColumbusEgyesült ÁllamokFut, nem toboroz
The University of FloridaGainesvilleEgyesült ÁllamokFut, nem toboroz
The University of Texas MD Anderson Cancer CenterHoustonEgyesült ÁllamokToborzás még nem indult
UT Health HoustonHoustonEgyesült ÁllamokToboroz
Memorial Sloan-Kettering Cancer CenterNew YorkEgyesült ÁllamokToborzás még nem indult
University of Nebraska Medical CenterOmahaEgyesült ÁllamokFut, nem toboroz

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