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Control/Waitlist (Anxiety Group) for Cancer

N/A
Waitlist Available
Led By Erin O Bantum, PhD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 16 weeks
Awards & highlights

Study Summary

This trial looks at whether mindfulness meditation via a mobile app can help cancer survivors with anxiety, pain, fatigue, trauma, and sleep.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the impact of Mindfulness Coach on Quality of Life as measured with the FACT scale (Neuropathy Arm)
Evaluate the impact of Mindfulness Coach on anxiety as measured with the PROMIS anxiety (Neuropathy Arm)
Fatigue
+6 more
Secondary outcome measures
Evaluate the satisfaction with Mindfulness Coach
Evaluate the satisfaction with Mobile Mindfulness Meditation as measured by questionnaires on the Online Mindful Meditation platforms (Anxiety Arm)

Trial Design

4Treatment groups
Active Control
Group I: Control/Waitlist (Anxiety Group)Active Control1 Intervention
Subjects assigned to this arm will not be offered access to the mobile app during the first 8 weeks of their participation. Subjects will be asked to begin using the app eight weeks after randomization. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week time point (just before subject begins using the mobile app) and 16 week time point.
Group II: Control/Waitlist (Neuropathy Group)Active Control1 Intervention
Subjects assigned to this arm will not be offered access to the mobile app during the first 8 weeks of their participation. Subjects will be asked to begin using the app eight weeks after randomization. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week time point (just before subject begins using the mobile app) and 16 week time point.
Group III: Mindfulness App (Neuropathy Group)Active Control1 Intervention
Subjects assigned to this arm will receive mindfulness meditation instructions for 8 consecutive weeks following randomization to this arm. The mobile app contains 14 sessions that subject can participate in at their own pace. Subjects are asked to try and practice mindfulness meditation daily, for a total time of 2 hours per week. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week and 16 week time points.
Group IV: Mindfulness App (Anxiety Group)Active Control1 Intervention
Subjects assigned to this arm will receive mindfulness meditation instructions for 8 consecutive weeks following randomization to this arm. The mobile app contains 14 sessions that subject can participate in at their own pace. Subjects are asked to try and practice mindfulness meditation daily, for a total time of 2 hours per week. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week and 16 week time points.

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Who is running the clinical trial?

University of HawaiiLead Sponsor
115 Previous Clinical Trials
54,387 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
88 Previous Clinical Trials
56,601 Total Patients Enrolled
Erin O Bantum, PhDPrincipal InvestigatorUniversity of Hawaii Cancer Research Center
~50 spots leftby Jun 2025
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