ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Mobile Digital Solution for Cancer Care and Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03094741
Recruitment Status : Active, not recruiting
First Posted : March 29, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
CancerLife
Information provided by (Responsible Party):
John Wayne Cancer Institute

Brief 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).

Condition or disease Intervention/treatment Phase
Cancer Caregivers Quality of Life Other: CancerLife Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : January 3, 2019
Estimated Study Completion Date : January 3, 2019

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.




Primary Outcome Measures :
  1. Feasibility/ Participation Rate [ Time Frame: 4 weeks ]
    number of individuals who participate in the study divided by the number of individuals who opened the link


Secondary Outcome Measures :
  1. Open Rate [ Time Frame: 4 weeks ]
    number of individuals who open the link divided by total number of individuals reached by the advertisement

  2. Refusal rate [ Time Frame: 4 weeks ]
    number of individuals who declined to participate divided by the number of individuals who opened the link

  3. Retention rate [ Time Frame: 4 weeks ]
    number of mission data divided by total number of items available

  4. Rate of missing data [ Time Frame: 4 weeks ]
    number of mission data divided by total number of items available

  5. Participant Satisfaction [ Time Frame: 4 weeks ]
    describe the usability, satisfaction, and desirability of the Mobile Digital Solution using a patient experience survey at the end of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094741


Locations
United States, California
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
John Wayne Cancer Institute
CancerLife
Investigators
Study Chair: Santosh Kesari, MD, PhD John Wayne Cancer Institute

Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT03094741     History of Changes
Other Study ID Numbers: JWCI-17-0301
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No