Mindfulness for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Altered mental status, Non-English speaking

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

Compensation: Varies

Number of Visits: 1

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer. The main questions this study aims to answer are: * Is it possible to use video-based coping strategies to help manage pain and distress after surgery? * Is one type of coping strategy better than another? Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress. Participants will: * Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging. * Fill out some questionnaires before surgery, which should take 10-15 minutes. * Be assigned to one of three coping strategies. * Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials. * Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials. * Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on coping strategies rather than medication changes.

Is mindfulness safe for cancer patients?

Mindfulness-based interventions are generally considered safe for cancer patients, with studies showing benefits like reduced stress and improved sleep quality. However, some research suggests that potential adverse effects have not been extensively studied, so it's important to discuss any concerns with your healthcare provider. ^{1 2 3 4 5}

How is the mindfulness treatment for cancer different from other treatments?

This mindfulness treatment is unique because it is delivered online, making it more accessible for cancer patients who may find it difficult to attend in-person sessions. It focuses on improving psychological well-being and reducing symptoms like anxiety and depression, which are often not the primary targets of traditional cancer treatments. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Mindfulness Intervention for cancer patients?

Research shows that mindfulness-based interventions can help reduce psychological distress, improve quality of life, and decrease symptoms like sleep disturbance and fatigue in cancer patients. These treatments also promote personal growth and may positively affect immune function and stress regulation, although the exact health benefits of these biological changes are still being studied. ^{1 6 8 9 10}

Are You a Good Fit for This Trial?

This trial is for cancer patients experiencing psychological distress post-surgery. Participants must provide contact details and agree to be contacted, fill out questionnaires, and follow assigned coping strategies using video resources before and after surgery.

Inclusion Criteria

I am having surgery for cancer in my abdomen.

Exclusion Criteria

Non-English speaking

My thinking or awareness is not clear due to delirium or medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Surgery Preparation

Participants fill out questionnaires and review video-based coping strategies before surgery

1 week

Virtual engagement

Post-Surgery Intervention

Participants review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress

1 week

Virtual engagement

Follow-up

Participants complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery to assess various outcomes

6 months

Virtual engagement

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Intervention
• Non-mindfulness Intervention

Trial Overview The study tests if video-based mindfulness interventions (like guided meditation) are more effective than non-mindfulness methods (like support from social workers) in managing pain and distress after cancer surgery.

How Is the Trial Designed?

Group I: Video-based Guided Mindfulness Experimental Treatment 1 Intervention

A 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress.

Group II: Video-based Guided Expressive Writing Experimental Treatment 1 Intervention

A 15-20-minute video based on expressive writing prompts aimed at addressing pain and distress. If the patient is assigned expressive writing, they will be offered a blank journal to use for the expressive writing interventions after randomization.

Group III: Non-Mindfulness Based Therapeutic Approaches Active Control 1 Intervention

Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) significantly reduce psychological distress in cancer patients and survivors, with a small but meaningful effect size (Hedges's g = 0.32) observed immediately after the intervention and a sustained effect (g = 0.19) at follow-up, based on a systematic review of 29 randomized controlled trials involving 3274 participants.

MBIs also positively impact secondary outcomes such as anxiety, depression, and sleep disturbances, with larger effects noted in studies that adhered closely to MBI protocols and involved younger participants, indicating that optimizing these interventions could enhance their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. Cillessen, L., Johannsen, M., Speckens, AEM., et al.[2021]

The 4-week internet-delivered mindfulness-based cancer recovery (iMBCR) program significantly reduced symptom burden in breast cancer patients compared to a control group, with improvements maintained one month after the intervention.

Participants in the iMBCR group also experienced significant enhancements in health-related quality of life (HRQoL), indicating that this online program is an effective and accessible alternative to traditional mindfulness interventions for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a 4-Week Internet-Delivered Mindfulness-Based Cancer Recovery Intervention on the Symptom Burden and Quality of Life of Patients With Breast Cancer: Randomized Controlled Trial. Wang, L., Chen, X., Peng, Y., et al.[2022]

Mindfulness-based interventions in cancer care have shown significant improvements in various areas such as anxiety, depression, stress, and even immune function, based on a systematic review of 13 research papers and 4 conference abstracts published since 2007.

Despite the promising results, the diversity in study designs and interventions presents challenges in making direct comparisons, indicating a need for further research to refine these mindfulness approaches in both acute treatment and palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the evidence for the use of mindfulness-based interventions in cancer care? A review. Shennan, C., Payne, S., Fenlon, D.[2022]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce psychological distress, sleep disturbances, and fatigue in cancer patients, while also promoting personal growth in quality of life and spirituality.

There is emerging evidence that MBIs may positively influence biological markers related to immune function and stress regulation, although it is still uncertain if these changes lead to meaningful health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Rouleau, CR., Garland, SN., Carlson, LE.[2020]

Mindfulness-based interventions are gaining popularity in psychosocial care, particularly for cancer patients and survivors, highlighting their potential benefits in managing stress and improving mental health.

The article emphasizes the need for clinicians to consider the specific relevance of mindfulness techniques for oncology patients, as well as the potential impact of mindfulness's religious origins on its application in psychosocial care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and psychosocial care in cancer: historical context and review of current and potential applications. Greene, PB., Philip, EJ., Poppito, SR., et al.[2018]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

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]

Mindfulness-based interventions (MBIs) significantly reduce symptoms of depression, anxiety, and cancer-related fatigue (CRF) in cancer patients, with medium effect sizes maintained for at least three months after the intervention.

In a review of 36 studies involving 1,677 participants, MBIs were found to be more effective than control groups in alleviating anxiety and CRF symptoms, highlighting their potential as a valuable component of oncological treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. Chayadi, E., Baes, N., Kiropoulos, L.[2022]

Online mindfulness-based interventions have been shown to effectively reduce distress, depression, stress, and sleep disturbances in adult cancer patients, based on a review of 10 randomized controlled trials involving 962 participants.

These interventions also improved the quality of life for cancer patients, suggesting they can be a valuable complementary therapy in managing cancer-related symptoms, although they did not significantly impact anxiety or other psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online mindfulness-based interventions for cancer patients: a systematic review and meta-analysis. Fan, M., Wang, Y., Zheng, L., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Effect of a 4-Week Internet-Delivered Mindfulness-Based Cancer Recovery Intervention on the Symptom Burden and Quality of Life of Patients With Breast Cancer: Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

What is the evidence for the use of mindfulness-based interventions in cancer care? A review. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness and psychosocial care in cancer: historical context and review of current and potential applications. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

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

The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of online mindfulness-based interventions for cancer patients: a systematic review and meta-analysis. [2023]