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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.

Find a Location

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
87 Previous Clinical Trials
56,561 Total Patients Enrolled
Erin O Bantum, PhDPrincipal InvestigatorUniversity of Hawaii Cancer Research Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size for this research endeavor?

"Affirmative. Clinicaltrials.gov lists the trial as actively recruiting; it was initially posted on April 3rd 2019 and subsequently updated on October 14th 2022. 400 people are expected to register from two different sites."

Answered by AI

Are there presently any open slots for enrolment in this clinical trial?

"Affirmative, the clinical trial is actively recruiting for its 400 participants. The information was first posted on April 3rd 2019 and modified lastly on October 14th 2022. Two separate sites are involved in this effort."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors
2019. "Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03581357.
~50 spots leftby Apr 2025
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