21 Participants Needed

App-Based Mindfulness for Kidney Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
Must be taking: Immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment App-Based Mindfulness Intervention for kidney cancer?

Research shows that mindfulness interventions, including app-based ones, can help reduce distress and improve quality of life in cancer patients, as seen in studies with breast, prostate, and colorectal cancer patients.12345

Is app-based mindfulness safe for cancer patients?

Research on app-based mindfulness for cancer patients shows it is generally safe, with studies reporting no significant safety concerns. Participants experienced benefits like reduced stress and improved quality of life, suggesting it is a safe option for managing symptoms.15678

How is the App-Based Mindfulness Intervention treatment different from other treatments for kidney cancer?

The App-Based Mindfulness Intervention is unique because it uses a mobile app to deliver mindfulness training, which can help reduce stress and improve quality of life for cancer patients, unlike traditional treatments that focus on physical symptoms.178910

What is the purpose of this trial?

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.

Research Team

SK

Sumanta K Pal

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.
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Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Device feasibility (app-based mindfulness program)Experimental Treatment3 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.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]
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.
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]

References

A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. [2020]
Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. [2023]
Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]
The role of mindfulness in distress and quality of life for men with advanced prostate cancer. [2019]
Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. [2023]
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. [2020]
Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. [2022]
Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]
Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. [2023]
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