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

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Caregivers
• Intervention / Treatment: Other: CancerLife

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute at Providence Saint John's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CancerLife Feasibility Group; Participants will be recruited through advertisements targeted to a specific audience using the keywords cancer and cancer survivors	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility/ Participation Rate	number of individuals who participate in the study divided by the number of individuals who opened the link	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open Rate	number of individuals who open the link divided by total number of individuals reached by the advertisement	4 weeks
Refusal rate	number of individuals who declined to participate divided by the number of individuals who opened the link	4 weeks
Retention rate	number of mission data divided by total number of items available	4 weeks
Rate of missing data	number of mission data divided by total number of items available	4 weeks
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

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Collaborators: CancerLife
• Investigators: Study Chair: Santosh Kesari, MD, PhD, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: JWCI-17-0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No