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?

This trial explores whether video-based coping strategies can ease pain and distress after cancer surgery. It compares mindfulness techniques, such as guided meditation and expressive writing (mindfulness intervention), with other supportive resources, like assistance from social workers and health education (non-mindfulness intervention). The goal is to determine if these strategies can smooth recovery and identify the most effective method. Patients undergoing abdominal cancer surgery who speak English are suitable candidates for this study. Participants will watch videos and complete short questionnaires before and after surgery to track changes in pain and distress. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance recovery experiences for future cancer surgery patients.

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.

What prior data suggests that these video-based coping strategies are safe for patients undergoing cancer surgery?

Research has shown that mindfulness and expressive writing are generally safe for people with cancer. Mindfulness practices, such as meditation, usually carry low risk. Studies have found they help with pain and stress, though few have investigated negative effects.

Expressive writing also appears safe and has been linked to better physical and mental health for cancer patients. Many studies have found it improves quality of life and reduces distress.

Both mindfulness and expressive writing demonstrate positive effects without major safety concerns. However, individuals should consider their own health and consult their doctor before starting anything new. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mindfulness interventions being explored for cancer patients because they offer a non-pharmacological approach to managing pain and distress. Unlike standard treatments like medication and therapy, these interventions use video-based guided mindfulness and expressive writing, tapping into the mind's ability to influence wellbeing. The mindfulness method involves guided meditation videos to help patients manage pain and stress, while the expressive writing approach encourages reflection through journaling. These techniques could complement existing care options, potentially reducing the reliance on medications and offering a more holistic way to support cancer patients' mental health.

What evidence suggests that this trial's video-based coping strategies could be effective for managing pain and distress after cancer surgery?

Studies have shown that mindfulness activities, such as guided meditation, can improve mental health and quality of life for cancer patients. In this trial, participants may receive a video-based guided mindfulness intervention to address pain and distress. Some research suggests these methods may also help with sleep problems, although they might not be as effective for pain and tiredness.

Another arm of this trial involves video-based guided expressive writing. This method has been studied and found to benefit both mental and physical health in cancer patients. Many studies report that expressive writing can enhance quality of life and physical health. Both video-based approaches in this trial aim to help patients manage pain and stress after surgery. ^{1 5 6 7 8}

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

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]

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 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]

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 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) 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05859880

Expressive Writing for Caregivers of Persons With Cancer The goal of this clinical trial is to test the effects of an expressive writing intervention for caregivers of persons with cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6680178/

The effect of expressive writing intervention on ... This study aimed to evaluate the effectiveness of expressive writing intervention (EWI) for improving psychological and physical health in cancer patients ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/07347332.2025.2454497?af=R

A mixed methods pilot study of a virtual therapeutic writing ... To evaluate the feasibility and acceptability of a virtual therapeutic writing intervention for AYAs with cancer.

4. withpower.com withpower.com/trial/phase-quality-of-life-qol-5-2023-23b1f

Expressive Writing Intervention for Emotional Distress in ... Trial Overview The study tests if group-based expressive writing via videoconference can improve mood and quality of life in caregivers of cancer patients.

5. cambridge.org cambridge.org/core/journals/palliative-and-supportive-care/article/expressive-writing-interventions-in-patients-with-cancer-a-scoping-literature-review/32C03C3461A4BECB9AE7A6B6796DF538

Expressive writing interventions in patients with cancer Twenty-one of the quantitative studies found that EWIs were positively associated with cancer patients' QOL and/or physical health outcomes. Of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924000760

Using expressive writing to improve cancer caregiver and ... This study examined the feasibility and preliminary efficacy of Expressive Writing (EW) in improving informal cancer caregiver (IC) and patient health.

7. ijmio.com ijmio.com/the-effects-of-expressive-writing-intervention-in-cancer-patients-and-survivors-a-rapid-umbrella-review/

The effects of expressive writing intervention in cancer ... The purpose of this review was to assess the effects of EWI on health outcomes in cancer patients using systematic reviews with or without meta-analyses.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0131802

Effect of Expressive Writing Intervention on Health Outcomes ... Effects of an expressive writing intervention on cancer-related distress in Danish breast cancer survivors–results from a nationwide randomized clinical trial.