2022-03-10
2022-12-02
2022-12-15
352
NCT05227898
Blue Note Therapeutics
Blue Note Therapeutics
INTERVENTIONAL
Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With 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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-01-06 | N/A | 2022-10-18 |
2022-01-22 | N/A | 2022-10-25 |
2022-02-08 | N/A | 2022-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Attune™ Attune™ is a completely digital therapeutic intervention. | DEVICE: Device: Attune™
|
| ACTIVE_COMPARATOR: Cerena™ Cerena™ is a completely digital therapeutic intervention. | DEVICE: Device: Cerena™
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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