App-Based Mindfulness for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Immunotherapy

Disqualifiers: Major depressive, Bipolar, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mindfulness app can improve the quality of life for people with kidney cancer that has spread. Participants will use the app for 20-30 minutes a day, at least four times a week, for a month. The study seeks individuals receiving immunotherapy for metastatic kidney cancer, who feel anxious about their cancer worsening, and have a smartphone with internet access. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance well-being alongside existing treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves mindfulness and not a new drug, it's likely you can continue your current treatments.

What prior data suggests that this app-based mindfulness intervention is safe for patients with metastatic kidney cancer?

Research has shown that mindfulness apps are generally easy for people to use. In a previous study with 50 patients who had advanced kidney cancer, 96% completed their check-ins after four weeks, indicating that most people stick with the app without major issues.

Another study on different mindfulness apps found that while some people stopped using them, most continued. This suggests that using a mindfulness app is usually safe and manageable for many. Additionally, there are no reports of serious side effects, making these apps a low-risk way to improve mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for kidney cancer, which often involve surgery, chemotherapy, or targeted drug therapies, the app-based mindfulness program offers a completely different approach. This treatment is unique because it uses a digital delivery method, allowing patients to engage in mindfulness exercises conveniently from their smartphones. It aims to improve mental well-being and potentially enhance quality of life. Researchers are excited about this treatment because it provides a non-invasive, low-risk option that can be easily integrated into patients' daily routines, which might help reduce stress and improve overall health outcomes.

What evidence suggests that this app-based mindfulness intervention is effective for improving quality of life in patients with metastatic kidney cancer?

Research has shown that a mindfulness app can improve the quality of life for people with advanced kidney cancer. In one study with 50 patients, 96% completed the program, indicating ease of use and participant satisfaction. Regular app users reported reduced stress and improved quality of life. Another study found that an 8-week mindfulness program improved sleep and reduced stress. These findings suggest that the mindfulness app, which participants in this trial will use for 20-30 minutes daily over 4 weeks, can help patients manage their condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Sumanta K Pal

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with metastatic renal cell carcinoma who haven't practiced meditation regularly in the past year, have a significant fear of cancer progression, and have not been part of mindfulness-based recovery or stress reduction programs within 5 years. Participants must own a smartphone with internet access, be fluent in English, and currently be receiving immunotherapy.

Inclusion Criteria

My cancer has spread, confirmed by CT scans of my chest, abdomen, and pelvis.

I am currently receiving immunotherapy.

I do not have major depression, bipolar, or other severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a mindfulness-based program using the Am app for 20-30 minutes every day, a minimum of 4 days each week over 4 weeks

4 weeks

Follow-up

Participants are monitored for psychosocial outcomes, quality of life, and fatigue over a 3-month period

3 months

What Are the Treatments Tested in This Trial?

Interventions

• App-Based Mindfulness Intervention

Trial Overview

The study tests an app-based mindfulness program to see if it can improve life quality for those with advanced kidney cancer. It involves using the app to engage in mindfulness exercises and completing questionnaires about their experience and feelings.

How Is the Trial Designed?

Group I: Device feasibility (app-based mindfulness program) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Mindfulness-based therapy (MBT) significantly reduces anxiety, depression, fear of recurrence, and fatigue in breast cancer patients, based on a meta-analysis of seven studies involving 951 participants.

MBT also improves emotional well-being, physical function, and physical health in these patients, suggesting it could be a valuable complementary treatment alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. Zhang, J., Xu, R., Wang, B., et al.[2022]

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., et al.[2021]

A pilot study involving 35 cancer patients showed that a smartphone-based meditation app is feasible and acceptable, with a 61% enrollment rate and 71% adherence over two weeks.

Participants using the app reported significant improvements in anxiety, fatigue, and overall distress, particularly with longer meditation sessions (15 minutes), suggesting the app could be a beneficial tool for managing mood symptoms in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. Lopez, G., Chaoul, A., Warneke, CL., et al.[2023]

Women with breast cancer who used a mobile app for mindfulness training reported significantly higher quality of life compared to those in the waitlist control group over an 8-week period.

The mindfulness training also led to increased dispositional mindfulness in participants, indicating that the app may help improve mental well-being alongside physical health after a breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. Rosen, KD., Paniagua, SM., Kazanis, W., et al.[2022]

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

The Being Present audio-based mindfulness meditation program, tested over 8 weeks with 53 participants (33 patients and 20 caregivers), showed significant reductions in distress and anxiety levels among patients with metastatic colorectal cancer and their caregivers.

Participants reported high adherence to the program, with 59% practicing mindfulness regularly, and 79% expressed intentions to continue practicing after the study, indicating the program's feasibility and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. Atreya, CE., Kubo, A., Borno, HT., et al.[2023]

This study investigates the effectiveness of an online Mindfulness-Based Cancer Recovery (MBCR) program delivered during chemotherapy, focusing on reducing fatigue in breast and colorectal cancer patients, with a target sample size of 178 participants.

If successful, the MBCR program could serve as an important adjunctive treatment during chemotherapy, potentially improving not only fatigue but also other symptoms like sleep disturbance, pain, and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy. Carlson, LE., Subnis, UB., Piedalue, KL., et al.[2020]

Participation in an 8-week mindfulness-based stress reduction (MBSR) program significantly improved quality of life, reduced stress symptoms, and enhanced sleep quality in 59 cancer patients (49 with breast cancer and 10 with prostate cancer).

The study also revealed changes in cytokine production, indicating a shift in immune response, with increased IL-4 and decreased IFN-gamma and IL-10, suggesting a move towards a healthier immune profile associated with reduced depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Carlson, LE., Speca, M., Patel, KD., et al.[2023]

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App-Based Mindfulness for Kidney Cancer

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