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

21 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 7 8 9 10}

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

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.

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

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+

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.

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States 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. [2023]

3. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The role of mindfulness in distress and quality of life for men with advanced prostate cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. [2023]

6. England 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. [2020]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. [2023]