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

Primary Purpose

Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device feasibility (app-based mindfulness program)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility metric 1
At least 90% of desired accrual is reached within 3 months (Yes or No)
Feasibility metric 2
At least 70% of patients are able to complete at least 2 of 4 intended intervention sessions for at least 2 of 4 weeks (Yes or No)
Feasibility metric 3
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety and Fear of Cancer Recurrence. (Yes or No)
Feasibility metric 4
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) depression. (Yes or No)
Fear of Cancer Recurrence-7
7-item scale that assesses the degree of FCR, with a cutoff score of 17 or above indicative of moderate and a cutoff score of 27 or above indicative of severe FCR. Reported as low, moderate, severe. Count and percentages provided for each level.
PROMIS Emotional Distress: Anxiety
This 8-item measure assesses symptoms of anxiety on a 5-point scale (1=never, 5=always). Scores range from 7-35 with higher scores indicating greater severity of anxiety. Data reported as continuous measure: means, standard deviation/ median range to be provided.
PROMIS Emotional Distress: Depression
This 8-item measure assesses symptoms of depression on a 5-point scale (1=never, 5=always). Scores range from 8-40 with higher scores indicating greater severity of depression. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Overall
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-108 for the total score. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Physical
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the physical. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Social/ Family
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the social/family. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Functional
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0 to 28 for the functional subscales. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Emotional
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-24 for the emotional subscale. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Mindfulness Attention Awareness Scale (MAAS)
A 15-item scale, designed to assess characteristics associated with mindfulness, such as: open or receptive awareness of and attention to what is taking place in the present. Participants use a scale from 1 to 6 (almost always - almost never), to indicate how frequently or infrequently they have each experience. Higher scores reflect higher levels of dispositional mindfulness. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Brief Fatigue Inventory (BFI): Fatigue severity
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Brief Fatigue Inventory (BFI): Fatigue Interferance
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2020
Last Updated
March 10, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04788095
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device feasibility (app-based mindfulness program)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Participate in an app-based mindfulness program
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility metric 1
Description
At least 90% of desired accrual is reached within 3 months (Yes or No)
Time Frame
3 months
Title
Feasibility metric 2
Description
At least 70% of patients are able to complete at least 2 of 4 intended intervention sessions for at least 2 of 4 weeks (Yes or No)
Time Frame
3 months
Title
Feasibility metric 3
Description
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety and Fear of Cancer Recurrence. (Yes or No)
Time Frame
3 months
Title
Feasibility metric 4
Description
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) depression. (Yes or No)
Time Frame
3 months
Title
Fear of Cancer Recurrence-7
Description
7-item scale that assesses the degree of FCR, with a cutoff score of 17 or above indicative of moderate and a cutoff score of 27 or above indicative of severe FCR. Reported as low, moderate, severe. Count and percentages provided for each level.
Time Frame
3 months
Title
PROMIS Emotional Distress: Anxiety
Description
This 8-item measure assesses symptoms of anxiety on a 5-point scale (1=never, 5=always). Scores range from 7-35 with higher scores indicating greater severity of anxiety. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
PROMIS Emotional Distress: Depression
Description
This 8-item measure assesses symptoms of depression on a 5-point scale (1=never, 5=always). Scores range from 8-40 with higher scores indicating greater severity of depression. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Overall
Description
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-108 for the total score. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Physical
Description
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the physical. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Social/ Family
Description
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the social/family. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Functional
Description
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0 to 28 for the functional subscales. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Emotional
Description
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-24 for the emotional subscale. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Mindfulness Attention Awareness Scale (MAAS)
Description
A 15-item scale, designed to assess characteristics associated with mindfulness, such as: open or receptive awareness of and attention to what is taking place in the present. Participants use a scale from 1 to 6 (almost always - almost never), to indicate how frequently or infrequently they have each experience. Higher scores reflect higher levels of dispositional mindfulness. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Brief Fatigue Inventory (BFI): Fatigue severity
Description
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months
Title
Brief Fatigue Inventory (BFI): Fatigue Interferance
Description
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumanta K Pal
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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