Evaluation of a Mobile App to Promote Social Support for Oncology Patients
NCT04331678
ABOUT THIS STUDY
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- 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
- Unable to communicate in English.
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Descriptive Information | |||||||||
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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 |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | West Cancer Center | ||||||||
Study Sponsor ICMJE | West Cancer Center | ||||||||
Collaborators ICMJE |
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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 |