BRAVE: Building Resilience and Values Through E-health

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05227599

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Survivorship	Other: Online survey questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

BRAVE: Building Resilience and Values Through E-health

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Online survey questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	San Francisco	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT05227599

Other Study ID Numbers:

IRB-55183

First Posted:

Feb 7, 2022

Last Update Posted:

Feb 7, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 7, 2022