Evaluation of a Mobile Digital Solution for Cancer Care and Research

Cancer Clinical Trial

Official title:

Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094741
• Other study ID #: JWCI-17-0301
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: November 5, 2020

Study information

• Verified date: February 2021
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 5, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Caregivers
• Quality of Life

Intervention

Other:
• CancerLife
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.

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute at Providence Saint John's Health Center	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
John Wayne Cancer Institute	CancerLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility/ Participation Rate	number of individuals who participate in the study divided by the number of individuals who opened the link	4 weeks
Secondary	Open Rate	number of individuals who open the link divided by total number of individuals reached by the advertisement	4 weeks
Secondary	Refusal rate	number of individuals who declined to participate divided by the number of individuals who opened the link	4 weeks
Secondary	Retention rate	number of mission data divided by total number of items available	4 weeks
Secondary	Rate of missing data	number of mission data divided by total number of items available	4 weeks
Secondary	Participant Satisfaction	describe the usability, satisfaction, and desirability of the Mobile Digital Solution using a patient experience survey at the end of the study	4 weeks