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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2025-12-30

Brief Summary

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This trial tests the feasibility of an application (app)-based mindfulness intervention and its effect on improving quality of life in patients with renal cell cancer that has spread to other places in the body (metastatic). This trial aims to see whether an app-based mindfulness intervention may help patients cope with their disease.

Detailed Description

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PRIMARY OBJECTIVES:

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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Metastatic Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in an app-based mindfulness program

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Participate in an app-based mindfulness program

Intervention Type BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Sufficiently fluent in English
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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NCI-2020-10496

Identifier Type: REGISTRY

Identifier Source: secondary_id

20310

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20310

Identifier Type: -

Identifier Source: org_study_id

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