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Completed

NCT Number: NCT03094741

Evaluation of a Mobile Digital Solution for Cancer Care and Research

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).

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Key information

Conditions

Cancer Caregivers Neoplasms Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CancerLife

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint John's Cancer Institute

Other

Collaborators

  • CancerLife

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2017
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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