App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer

City of Hope

Status

Active, not recruiting

Conditions

Metastatic Renal Cell Carcinoma

Stage IV Renal Cell Cancer AJCC v8

Treatments

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Behavioral: Behavioral Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04788095

P30CA033572 (U.S. NIH Grant/Contract)

20310 (Other Identifier)

NCI-2020-10496 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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