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App-Based Mindfulness for Kidney Cancer
N/A
Waitlist Available
Led By Sumanta K Pal
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not suffering from current major depressive disorder, bipolar disorder or other psychiatric disorder
Evidence of metastatic disease (including at a minimum computed tomography [CT] of the chest, abdomen and pelvis for staging)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing whether an app-based mindfulness intervention can help improve quality of life for patients with metastatic renal cell cancer.
Who is the study for?
This trial is for patients with metastatic renal cell carcinoma who haven't practiced meditation regularly in the past year, have a significant fear of cancer progression, and have not been part of mindfulness-based recovery or stress reduction programs within 5 years. Participants must own a smartphone with internet access, be fluent in English, and currently be receiving immunotherapy.Check my eligibility
What is being tested?
The study tests an app-based mindfulness program to see if it can improve life quality for those with advanced kidney cancer. It involves using the app to engage in mindfulness exercises and completing questionnaires about their experience and feelings.See study design
What are the potential side effects?
Since this intervention is behavioral involving mindfulness practices through an app, there are no direct medical side effects like you would expect from medication or surgery. However, participants may experience emotional discomfort when confronting fears related to their illness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have major depression, bipolar, or other severe mental health issues.
Select...
My cancer has spread, confirmed by CT scans of my chest, abdomen, and pelvis.
Select...
I am currently receiving immunotherapy.
Select...
My kidney cancer diagnosis was confirmed through lab tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Fatigue Inventory (BFI): Fatigue Interferance
Brief Fatigue Inventory (BFI): Fatigue severity
Fear of Cancer Recurrence-7
+12 moreSide effects data
From 2013 Phase 1 & 2 trial • 16 Patients • NCT0192389613%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavioral Intervention & DCS
Behavioral Intervention & Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Device feasibility (app-based mindfulness program)Experimental Treatment3 Interventions
Patients participate in a mindfulness-based program by using the Am app for 20-30 minutes every day, a minimum of 4 days each week over 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,132 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,439 Total Patients Enrolled
Sumanta K PalPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
332 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread, confirmed by CT scans of my chest, abdomen, and pelvis.I am currently receiving immunotherapy.I do not have major depression, bipolar, or other severe mental health issues.My kidney cancer diagnosis was confirmed through lab tests.You feel very worried about your cancer getting worse, as shown by a score of 13 or more on a test about anxiety.You have not been regularly practicing meditation at least once a week in the past year.You have not taken part in a mindfulness program for cancer recovery or stress reduction in the last 5 years.You have a high level of fear about the cancer coming back, as shown by a score of 17 or more on the Fear of Cancer Recurrence-7 questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Device feasibility (app-based mindfulness program)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being included in this clinical experiment?
"Affirmative, the details provided on clinicaltrials.gov demonstrate that this investigation is actively recruiting volunteers. The trial was initially posted to the registry on August 23rd 2021 and last updated March 9th 2022; it aims to enlist 30 individuals at a single site."
Answered by AI
Is this experiment currently in the process of gathering participants?
"Affirmative, the information on clinicaltrials.gov suggests that this medical research project is actively looking for volunteers. The first posting of the trial was made on August 23rd 2021 and there have been recent updates to it as recently as March 9th 2022. 30 patients are needed from one single location in order to complete the study."
Answered by AI
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