CancerNCT05647785
Long-term Follow-up of RESTORE Study
An observational study of Cancer, run by Blue Note Therapeutics at 1 site in United States.
Trial summary
The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898). The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Long-term follow-up of cerena™ and Long-term follow-up of attune™
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 30 Jun 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of all interested patients who were enrolled and not withdrawn from the parent study (RESTORE).
Who may be able to join
- Enrolled in and not withdrawn from the original RESTORE study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Blue Note Therapeutics
San Francisco, California, 94104
About this study
Official title: Extension Study to Compare Long-term Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Cancer Patients Previously Enrolled in the RESTORE Study
The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898).
The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.
Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.
- Conditions
- Cancer
- Being tested
- Long-term follow-up of cerena™, Long-term follow-up of attune™
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term follow-up of cerena™Device
Long term follow-up for eligible participants from the RESTORE study
Long-term follow-up of attune™Device
Long term follow-up for eligible participants from the RESTORE study
| Study group | Role | What they receive |
|---|---|---|
| cerena™ | Subjects who took part in the cerena™ group during the original RESTORE study Receives: Device: Long-term follow-up of cerena™ | |
| attune™ | Subjects who took part in the attune™ group during the original RESTORE study Receives: Device: Long-term follow-up of attune™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety
The PROMIS-Anxiety (PROMIS-A) is a validated PRO consisting of 8 questions measuring anxiety symptoms. The change in PROMIS-A score over time will be assessed (reduction indicates reduced anxiety).
Measured: 3 and 6 months post RESTORE end-of-study
Secondary outcomes (8)
Symptoms of depression
The PROMIS-Depression (PROMIS-D) is a validated PRO consisting of 8 questions measuring depression symptoms. The change in PROMIS-D score over time will be assessed (decrease indicates reduced depression).
Measured: 3 and 6 months post RESTORE end-of-study
Symptoms of emotional distress
Change in PROMIS Emotional Distress; a composite of PROMIS-Anxiety and PROMIS-Depression over time (decrease indicates reduced emotional distress).
Measured: 3 and 6 months post RESTORE end-of-study
Cancer-related symptoms of anxiety (intrusions)
The Impact of Events Scale-Revised (IES-R) is used to assess subjective distress caused by a stressful life event, which in this study is cancer. The change in the IES-R Intrusion subscale score over time will be assessed (decrease indicates reduced intrusive symptoms related to cancer).
Measured: 3 and 6 months post RESTORE end-of-study
Wellbeing and quality of life
The Functional Assessment of Cancer Therapy - General (FACT-G) is designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The change in FACT-G scores over time will be assessed (increase indicates improved quality of life).
Measured: 3 and 6 months post RESTORE end-of-study
Stress management/coping skills
The Measure of Current Status (MOCS) Part A measures self-perceived status for using coping skills. The change in MOCS Part A scores over time will be assessed (increase indicates greater confidence in skill use ability).
Measured: 3 and 6 months post RESTORE end-of-study
Non-specific (social) intervention effects
The Measure of Current Status (MOCS) Part B assesses non-specific intervention effects - feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. The change in MOCS Part B scores over time will be assessed (increase indicates greater non-specific intervention effects).
Measured: 3 and 6 months post RESTORE end-of-study
Perceived stress
The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. The change in PSS scores over time will be assessed (higher PSS scores indicate higher perceived stress).
Measured: 3 and 6 months post RESTORE end-of-study
Benefit finding
The 17-item Benefit Finding Scale measures the perception that positive contributions were made to one's life by the experience of being diagnosed with and treated for cancer. Change in scores over time will be assessed (increase indicates increase in benefit finding).
Measured: 3 and 6 months post RESTORE end-of-study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start31 Oct 2022
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Note Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dianne M Shumay, PhD, Principal investigator, Blue Note Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647785
- Sponsor's protocol ID
- PROT005
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study to Compare Long-term Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Cancer Patients Previously Enrolled in the RESTORE Study
- ClinicalTrials.gov ID
- NCT05647785
- Acronym / sponsor ID
- PROT005
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Blue Note TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Dec 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 RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898).
The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.
Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerena™ | – | Device: Long-term follow-up of cerena™Subjects who took part in the cerena™ group during the original RESTORE study |
| attune™ | – | Device: Long-term follow-up of attune™Subjects who took part in the attune™ group during the original RESTORE study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of all interested patients who were enrolled and not withdrawn from the parent study (RESTORE).
Key inclusion criteria (1 listed)
- Enrolled in and not withdrawn from the original RESTORE study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Long-term follow-up of cerena™Long term follow-up for eligible participants from the RESTORE study | Device | cerena™ |
| Long-term follow-up of attune™Long term follow-up for eligible participants from the RESTORE study | Device | attune™ |
Primary outcome
Symptoms of anxiety
Time frame: 3 and 6 months post RESTORE end-of-study
The PROMIS-Anxiety (PROMIS-A) is a validated PRO consisting of 8 questions measuring anxiety symptoms. The change in PROMIS-A score over time will be assessed (reduction indicates reduced anxiety).
8 secondary outcomes
Symptoms of depression
Time frame: 3 and 6 months post RESTORE end-of-study
Symptoms of emotional distress
Time frame: 3 and 6 months post RESTORE end-of-study
Cancer-related symptoms of anxiety (intrusions)
Time frame: 3 and 6 months post RESTORE end-of-study
Wellbeing and quality of life
Time frame: 3 and 6 months post RESTORE end-of-study
Stress management/coping skills
Time frame: 3 and 6 months post RESTORE end-of-study
Non-specific (social) intervention effects
Time frame: 3 and 6 months post RESTORE end-of-study
Perceived stress
Time frame: 3 and 6 months post RESTORE end-of-study
Benefit finding
Time frame: 3 and 6 months post RESTORE end-of-study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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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.
Dianne M Shumay, PhD principal investigator
Blue Note Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Blue Note Therapeutics 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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?
Results are not available in the source record.
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?
Symptoms of anxiety (time frame: 3 and 6 months post RESTORE end-of-study). 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 12 Dec 2022.