- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03094741
Evaluation of a Mobile Digital Solution for Cancer Care and Research
Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called CancerLife that they can download (FREE) from their mobile device app store (Android or iOS). Participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. This data will be collected inside the application and display in easy to understand pie charts. Participants will also have the option to broadcast their entry to their social network.
Since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden and QOL data, the investigators will include a standard validated instrument (FACT-G: Functional Assessment of Cancer Therapy - General) as part of this study. Participants will be asked to complete the FACT-G after initial registration and weekly for up to 4 weeks. Participants will receive electronic mail messages with a link to CancerLife weekly as a reminder to access the website.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Santa Monica, California, Forente stater, 90404
- John Wayne Cancer Institute at Providence Saint John's Health Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Established diagnosis of cancer
- Karnofsky Index ≥50%
- Age > 18 years
Exclusion Criteria:
- Relevant cognitive impairment
- Insufficient knowledge of English language to complete the survey
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CancerLife Feasibility Group
Participants will be recruited through advertisements targeted to a specific audience using the keywords cancer and cancer survivors
|
CancerLife is a mobile digital solution that allows patients to broadcast their health status inside a private invitation only group, text, email or publicly in Facebook or Instagram.
By doing, so the patient collects his/her own patient-reported outcomes data and then share this data with their doctor or care team.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility/ Participation Rate
Tidsramme: 4 weeks
|
number of individuals who participate in the study divided by the number of individuals who opened the link
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Open Rate
Tidsramme: 4 weeks
|
number of individuals who open the link divided by total number of individuals reached by the advertisement
|
4 weeks
|
|
Refusal rate
Tidsramme: 4 weeks
|
number of individuals who declined to participate divided by the number of individuals who opened the link
|
4 weeks
|
|
Retention rate
Tidsramme: 4 weeks
|
number of mission data divided by total number of items available
|
4 weeks
|
|
Rate of missing data
Tidsramme: 4 weeks
|
number of mission data divided by total number of items available
|
4 weeks
|
|
Participant Satisfaction
Tidsramme: 4 weeks
|
describe the usability, satisfaction, and desirability of the Mobile Digital Solution using a patient experience survey at the end of the study
|
4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Santosh Kesari, MD, PhD, Saint John's Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- JWCI-17-0301
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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