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

NCT ID: NCT04331678

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-10-24

Brief Summary

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Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.

Detailed Description

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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.

Conditions

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Chemotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care

Participants will be complete survey at enrollment and then again in 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Comparator App

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

West Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West Cancer Center

Southaven, Mississippi, United States

Site Status

West Cancer Center

Germantown, Tennessee, United States

Site Status

West Cancer Center

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Graetz I, Hu X, Curry AN, Robles A, Vidal GA, Schwartzberg LS. Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial. Cancer Med. 2023 Mar;12(5):6190-6199. doi: 10.1002/cam4.5351. Epub 2022 Oct 18.

Reference Type DERIVED
PMID: 36258654 (View on PubMed)

Other Identifiers

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2018-002b

Identifier Type: -

Identifier Source: org_study_id