Clinical trial NCT04788095: App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Official title: Assessing Feasibility of an App-Based Mindfulness Intervention for Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Feasibility metric 1
timeFrame: 3 months
measure: Feasibility metric 2
timeFrame: 3 months
measure: Feasibility metric 3
timeFrame: 3 months
measure: Feasibility metric 4
timeFrame: 3 months
measure: Fear of Cancer Recurrence-7
timeFrame: 3 months
measure: PROMIS Emotional Distress: Anxiety
timeFrame: 3 months
measure: PROMIS Emotional Distress: Depression
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G): Overall
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G): Physical
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G): Social/ Family
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G): Functional
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G): Emotional
timeFrame: 3 months
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: 3 months
measure: Brief Fatigue Inventory (BFI): Fatigue severity
timeFrame: 3 months
measure: Brief Fatigue Inventory (BFI): Fatigue Interferance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Sumanta K Pal
role: PRINCIPAL_INVESTIGATOR
References: