Evaluation of a Mobile App to Promote Social Support for Oncology Patients

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NCT04331678

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Study Location
West Cancer Center
Southaven, Mississippi, 38671, United States
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Contact
9016830055
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chemotherapy Effect
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least 18 years of age

- Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy

- Have a valid email address

- Have a smart mobile device (Android or iOS) with a data plan

- Willing to download and use the study app

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Unable to communicate in English.

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Chemotherapy EffectEvaluation of a Mobile App to Promote Social Support for Oncology Patients
NCT04331678
  1. Southaven, Mississippi
  2. Germantown, Tennessee
  3. Memphis, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of a Mobile App to Promote Social Support for Oncology Patients
Official Title  ICMJE Evaluation of a Mobile App to Promote Social Support for Oncology Patients
Brief Summary Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.
Detailed Description The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chemotherapy Effect
Intervention  ICMJE Behavioral: Comparator App

Participants will download and agree to use the study app at least once per week during the 3-month intervention period.

The app allows participants to invite a network of friends and family to provide emotional and logistical support during their treatment.

Study Arms  ICMJE
  • No Intervention: Usual Care
    Participants will be complete survey at enrollment and then again in 3 months.
  • Active Comparator: Active

    Participants in the App group will receive usual care and complete survey at enrollment and then again in 3 months.

    In addition, they will be asked to download the study app to their mobile device and use it at least once per week during the 3-month study period.

    Intervention: Behavioral: Comparator App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2020)		460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
  • Have a valid email address
  • Have a smart mobile device (Android or iOS) with a data plan
  • Willing to download and use the study app

Exclusion Criteria:

  • Unable to communicate in English.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lee Schwartzberg, MD9016830055[email protected]
Contact: Andrea Curry, PhD9016830055[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331678
Other Study ID Numbers  ICMJE 2018-002b
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party West Cancer Center
Study Sponsor  ICMJE West Cancer Center
Collaborators  ICMJE
  • Pfizer
  • Emory University
Investigators  ICMJE Not Provided
PRS Account West Cancer Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP