Metastatic Renal Cell CarcinomaNCT04788095
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
A study testing Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- What is being tested?
- Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Assessing Feasibility of an App-Based Mindfulness Intervention for Patients With Metastatic Renal Cell Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Behavioral Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionDevice
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in an app-based mindfulness program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (app-based mindfulness program) | Experimental | 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. Receives: Device: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility metric 1
At least 90% of desired accrual is reached within 3 months (Yes or No)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start23 Aug 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta K Pal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788095
- Sponsor's protocol ID
- 20310
- Other IDs
- NCI-2020-10496, 20310, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Feasibility of an App-Based Mindfulness Intervention for Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04788095
- Acronym / sponsor ID
- 20310
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (app-based mindfulness program) | Experimental | Device: Behavioral Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in an app-based mindfulness program | Device | Device feasibility (app-based mindfulness program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Device feasibility (app-based mindfulness program) |
| Questionnaire AdministrationAncillary studies | Other | Device feasibility (app-based mindfulness program) |
Primary outcome
Feasibility metric 1
Time frame: 3 months
At least 90% of desired accrual is reached within 3 months (Yes or No)
Feasibility metric 2
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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)
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumanta K Pal principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility metric 1 (time frame: 3 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.