- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Santa Monica, California, Förenta staterna, 90404
- John Wayne Cancer Institute at Providence Saint John's Health Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility/ Participation Rate
Tidsram: 4 weeks
|
number of individuals who participate in the study divided by the number of individuals who opened the link
|
4 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Open Rate
Tidsram: 4 weeks
|
number of individuals who open the link divided by total number of individuals reached by the advertisement
|
4 weeks
|
|
Refusal rate
Tidsram: 4 weeks
|
number of individuals who declined to participate divided by the number of individuals who opened the link
|
4 weeks
|
|
Retention rate
Tidsram: 4 weeks
|
number of mission data divided by total number of items available
|
4 weeks
|
|
Rate of missing data
Tidsram: 4 weeks
|
number of mission data divided by total number of items available
|
4 weeks
|
|
Participant Satisfaction
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Santosh Kesari, MD, PhD, Saint John's Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- JWCI-17-0301
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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