Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer (RESTORE)

Two-arm, Double-blind, Randomized Controlled Trial to Compare Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Patients With Stage I-III Cancer

This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.

The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Device: Attune™; Device: Device: Cerena™

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94104
      • Www.Restoreclinicaltrial.Com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stage I-III cancer diagnosis
• Currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment.
• Are experiencing at least moderate anxiety
• 18 years of age or older
• Are fluent in English
• Have access to a smartphone (a mobile phone that performs many of the functions of a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications) or tablet that runs iOS or Android software, with cellular data service or wifi access.
• Willing to download software onto smartphone or tablet from Apple store or Android store

Exclusion Criteria:

• Systemic treatment plan includes only endocrine therapy.
• Treatment plan includes stem cell/bone marrow transplant.
• Currently participating in any other investigative CBT trial for treatment of anxiety or depression.
• Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study
• Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics device or Blue Note Therapeutics-sponsored study
• Are experiencing severe levels of depression OR indicate suicidal risk (measured by surveys during screening for the study)
• Are experiencing anxiety below the required level (measured by a survey during screening for the study)
• Cancer diagnosis is melanoma, multiple myeloma, unstaged cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attune™; Attune™ is a completely digital therapeutic intervention.	Device: Device: Attune™; People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.
Active Comparator: Cerena™; Cerena™ is a completely digital therapeutic intervention.	Device: Device: Cerena™; People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline up to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline up to week 12
Symptoms of emotional distress	Change in PROMIS Emotional Distress; a composite of PROMIS-Anxiety and PROMIS-Depression over time (decrease indicates reduced emotional distress).	Baseline up to week 12
Positive and negative affect	The Positive and Negative Affect Schedule Short Form (PANAS-SF) measures positive and negative affect. Change in PANAS-SF scores over time will be assessed (increase in Positive Affect Scale indicates increase in positive emotions and expression; decrease in Negative Affect Scale indicates decrease in negative emotions and expression).	Baseline up to week 12
Cancer-related symptoms of anxiety (thought intrusions)	The Impact of Events Scale-Revised (IES-R) is used to assess subjective distress caused by a stressful life event. The change in the IES-R Intrusion subscale mean score over time will be assessed (decrease in Intrusion score indicates reduced intrusive symptoms related to a specific stressor).	Baseline up to week 12
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 (a reduction in the FACT-G total score, derived from the subscale scores, indicates an increased health-related quality of life).	Baseline up to Week 12
Global Improvement-Likert Scale	The Global Improvement-Likert Scale uses a Likert scale to assess participant self-perception of the level of improvement of their overall well-being, symptoms of anxiety, and symptoms of depression since they began the study.	Baseline up to Week 12
Symptom-related distress	The Rotterdam Symptom Checklist (RSCL) is measures health-related quality of life of cancer patients. This study uses the same Likert scale and a subset of the symptoms ("eye strain" and "headache") that are part of the Rotterdam Symptom Checklist with the addition of the symptom "finger cramping" to monitor for all potential device adverse effects.	Baseline up to week 12
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).	Baseline up to Week 12
Level of stress management skill and coping skill efficacy (PAM)	The Patient Activation Measure (PAM) is used to assess the knowledge, skills, and confidence to manage one's health. The change in PAM scores over time will be assessed (higher PAM scores indicate higher patient activation).	Baseline up to Week 12
Level of stress management skill and coping skill efficacy (MOCS Part A)	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).	Baseline up to Week 12
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).	Baseline up to Week 12
Benefit Finding	The Benefit Finding Scale (BFS) assesses the perception that positive contributions were made to one's life by the experience of being diagnosed with and treated for cancer. The change in BFS scores over time will be assessed	Baseline up to Week 12
Safety of each digital product	Self-reported device related adverse events; 3-item Distress Assessment and Response Tool (DART) self-reported to monitor suicidality.	Baseline up to Week 12
Usability of each digital product	mHealth App Usability Questionnaire (MAUQ) mean scores will be measured at end of study (higher scores indicate higher ease of use / easier to use applications).	Week 12
Acceptability of each digital product	Net promoter score (NPS), an index ranging from -100 to 100 that measures willingness to recommend the digital products, will be measured at end of study.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization	Incidence of ER visits, hospitalization, 30-day readmission rates, and average LOS for hospitalization	Baseline up to Week 12

Collaborators and Investigators

• Sponsor: Blue Note Therapeutics
• Collaborators: Curebase Inc.
• Investigators: Principal Investigator: Dianne M Shumay, Blue Note Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): December 2, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Lung Cancer; Lymphoma; Prostate Cancer; Pancreatic Cancer; Leukemia; Ovarian Cancer; Endometrial Cancer; Thyroid Cancer; Colon/Rectal Cancer
• Other Study ID Numbers: PROT004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No