BRAVE: Building Resilience and Values Through E-health

September 10, 2023 updated by: Stanford University
The purpose of this study is to determine the feasibility and acceptability of tracking survivors' and their caregivers, stressors, affect, and symptoms using an electronic diary method, in the time period surrounding their routine check- up with their oncologist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 11-25 years old
  2. previously received a pediatric cancer diagnosis and treatment for such
  3. completed cancer treatment <5 years ago, in remission
  4. Own a smart phone or tablet
  5. are English proficient

Exclusion Criteria:

  • no cognitive, motor, or sensory deficits that could preclude completion of study measures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Daily Diary Method Cohort
Participants will be asked to complete a self-report questionnaire that has been validated to assess daily affect. There are 5 items assessing positive affect (joyful, cheerful, happy, lively, proud) and 5 items assessing negative affect (miserable, mad, afraid, scared sad). The respondent is asked to rate these 10 different feelings on a 5-point Likert scale from 1, "not much or not at all" to 5, "a lot."
Other: Online survey questionnaire
Participants will complete a brief online survey every morning and evening within 1 hour of waking and 1 hour of going to sleep. The surveys will be a combination of measures used to assess affect, stress, and symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Online survey questionnaire
Time Frame: 21 days
participants will complete a brief online survey every morning and evening within 1 hour of waking and 1 hour of going to sleep
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Claudia Mueller, MD, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

March 24, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-55183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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