App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
NCT ID: NCT04788095
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
21 participants
INTERVENTIONAL
2021-08-23
2025-12-30
Brief Summary
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Detailed Description
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I. To assess feasibility of the Am mindfulness app in metastatic renal cell carcinoma (mRCC) patients, with respect to accrual, adherence and engagement in program.
II. To assess preliminary effects of app-based mindfulness intervention in patients with metastatic renal cell carcinoma (mRCC) (the Am Mindfulness-Based Cancer Survivorship \[MBCS\] Journey), on psychosocial outcomes (e.g., anxiety, distress, fear of cancer recurrence), as well as overall quality of life (QOL) and fatigue, among patients with mRCC.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Device feasibility (app-based mindfulness program)
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.
Behavioral Intervention
Participate in an app-based mindfulness program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Intervention
Participate in an app-based mindfulness program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC)
* Evidence of metastatic disease (including at a minimum computed tomography \[CT\] of the chest, abdomen and pelvis for staging)
* Undergoing immunotherapy
* A "moderate" or greater fear of cancer progression, as demonstrated by an Fear of Cancer Recurrence-7 (FCR-7) score of \>= 17
* A fear of cancer progression, as demonstrated by a Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety score \>= 13
* Have smart phone with internet access
* Not suffering from current major depressive disorder, bipolar disorder or other psychiatric disorder
* Not currently engaging in meditation one or more times per week within the previous year
* Has not participated in an mindfulness-based cancer recovery (MBCR) or mindfulness-based stress reduction (MBSR) program in the past 5 years
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sumanta K Pal
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2020-10496
Identifier Type: REGISTRY
Identifier Source: secondary_id
20310
Identifier Type: OTHER
Identifier Source: secondary_id
20310
Identifier Type: -
Identifier Source: org_study_id
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