SurvivorshipNCT05227599
BRAVE: Building Resilience and Values Through E-health
A study testing Online survey questionnaire in people with Survivorship, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Survivorship
- What is being tested?
- Online survey questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- no cognitive, motor, or sensory deficits that could preclude completion of study measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
San Francisco, California, 94305
About this study
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.
- Conditions
- Survivorship
- Being tested
- Online survey questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online survey questionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Daily Diary Method Cohort | Other | 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." Receives: Other: Online survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Mar 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Mueller, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227599
- Sponsor's protocol ID
- IRB-55183
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVE: Building Resilience and Values Through E-health
- ClinicalTrials.gov ID
- NCT05227599
- Acronym / sponsor ID
- IRB-55183
- Conditions
- Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Diary Method Cohort | Other | Other: Online survey questionnaireParticipants 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." |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- no cognitive, motor, or sensory deficits that could preclude completion of study measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online survey questionnaireParticipants 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 | Other | Daily Diary Method Cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Mueller, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online survey questionnaire in people with Survivorship, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online survey questionnaire (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.