Mindfulness App for Gynecologic Cancers

(MECCA Trial)

Recruiting at 1 trial location

Overseen By Shannon Grabosch, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: St. Louis University

Disqualifiers: Non-English speaking, No smartphone, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Headspace mindfulness app can improve the quality of life for women with endometrial or cervical cancer. Participants will either use the app or not before undergoing treatment, and researchers will track their well-being and medication use. Women newly diagnosed with endometrial cancer preparing for surgery or cervical cancer beginning chemoradiation, who have a smartphone and are not already using Headspace, might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance quality of life during cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Headspace smartphone application is safe for patients with gynecologic cancers?

Research shows that mindfulness apps like Headspace are generally safe for use. Studies have found these apps easy to use and effective in reducing stress. For cancer patients, a mindfulness and relaxation app offers a practical way to support self-care.

For patients with endometrial and cervical cancer, no evidence suggests any safety issues with the Headspace app. This smartphone app guides users in meditation and stress relief and has been used successfully in many situations. Overall, the Headspace app is considered safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness App for Gynecologic Cancers trial because it explores a novel approach to managing quality of life for patients with endometrial and cervical cancers. Unlike typical treatments that focus on surgery or chemotherapy, this trial leverages the Headspace smartphone app to deliver mindfulness and meditation exercises. This method is unique because it is non-invasive and can be easily integrated into daily life, potentially enhancing mental well-being without additional medication. By tracking how mindfulness practices might reduce the need for pain medication and improve overall patient comfort, the trial could pave the way for more holistic cancer care options.

What evidence suggests that the Headspace app is effective for gynecologic cancers?

Research has shown that mindfulness apps like Headspace can improve the quality of life for cancer patients. In this trial, participants with endometrial or cervical cancer will be randomized to either use the Headspace app or not. Studies have found that using the Headspace app effectively lowers stress and anxiety. Specifically, one trial found that patients who used Headspace reported feeling better overall compared to those who did not use the app. This app guides users through meditation and mindfulness exercises, which can be helpful during challenging treatments like surgery or combined chemotherapy and radiation for endometrial and cervical cancer. Evidence from various studies supports the benefits of mindfulness, suggesting it is a useful tool for managing stress in cancer care. ^{1 2 3 6 7}

Who Is on the Research Team?

Shannon Grabosch, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals newly diagnosed with endometrial cancer scheduled for surgery, or cervical cancer to be treated with chemoradiation. Participants must have access to a smartphone and not currently use the Headspace app.

Inclusion Criteria

You need to have a smartphone.

I am newly diagnosed with endometrial or cervical cancer and will undergo surgery or radiation.

Exclusion Criteria

No access to smartphone

Non-English speaking

You are currently using the Headspace app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients with endometrial cancer undergo surgery or patients with cervical cancer receive chemoradiation, with randomization to use the Headspace app or not

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for opiate usage, quality of life, and complications post-treatment

4-6 weeks

1 visit (in-person), 1 phone call

Mindfulness Practice

Participants in the intervention group use the Headspace app for mindfulness exercises

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Headspace Smartphone Application

Trial Overview

The study is testing if using the Headspace smartphone application can improve quality of life in patients undergoing treatment for endometrial or cervical cancer. Patients are randomly chosen to either use the app or not before their treatment starts.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patients with endometrial cancer will be approached for participation at their pre-operative visit. Patients with cervical cancer will be approached at their pre-treatment visit. If the patient opts to participate, she will be randomized to utilize the Headspace smartphone application or not. She will be provided a three month gift subscription. Headspace will be downloaded to her smartphone and she will be instructed on use. Patients will be asked to complete a quality of life survey on the day of enrollment, the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer) and at their post-treatment visit. The patient will receive one phone call prior to her post-treatment visit requesting she bring her bottle of opiate pills with her for counting. The number of pills used will be recorded. The number of Headspace sessions will be recorded. An anonymous survey will be provided for completion. The patient will be provided a gift card at completion.

Group II: Control Active Control 1 Intervention

Patients with endometrial cancer will be approached for participation at their pre-operative visit. Patients with cervical cancer will be approached at their pre-treatment visit. If the patient opts to participate, she will be randomized to utilize the Headspace smartphone application or not. All patients in the control group may choose to practice calming or mindfulness exercises of their own accord but will not be specifically instructed to seek out such resources as is our standard practice. Patients will be asked to complete a quality of life survey on the day of enrollment, the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer) and at their post-treatment visit. The patient will receive one phone call prior to her post-treatment visit requesting she bring her bottle of opiate pills with her for counting. The number of pills used will be recorded. An anonymous survey will be provided for completion. The patient will be provided a gift card at completion.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Published Research Related to This Trial

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 mindfulness-based cognitive behavioral therapy intervention significantly improved sexual response in 31 gynecologic cancer survivors, with benefits observed in sexual desire and arousal after three sessions.

While the intervention increased participants' perception of genital arousal during erotic stimuli, it did not affect physiologically measured sexual arousal, indicating a potential disconnect between subjective and objective sexual responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer. Brotto, LA., Erskine, Y., Carey, M., et al.[2022]

The SafeSpace study tested a virtual reality intervention for cancer patients, showing it was acceptable and feasible, with 65% of participants completing three sessions.

Participants experienced significant improvements in mental well-being and reductions in stress levels after using the VR intervention, indicating its potential benefits for psychological support in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SafeSpace: what is the feasibility and acceptability of a codesigned virtual reality intervention, incorporating compassionate mind training, to support people undergoing cancer treatment in a clinical setting? O'Gara, G., Murray, L., Georgopoulou, S., et al.[2022]

The Mindfulness in Motion + Diet (MIM+D) intervention was found to be feasible for endometrial cancer survivors, with a high completion rate of 76% and 90% attendance at sessions, indicating good acceptability among participants.

While the overall program did not significantly improve outcomes for all participants, those who completed the program showed meaningful improvements in mindfulness and moderate changes in diet, physical activity, and health-related quality of life, suggesting potential benefits for adherent individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Lifestyle Intervention for Obese, Inactive Endometrial Cancer Survivors: A Feasibility Study. Lucas, AR., Focht, BC., Cohn, DE., et al.[2023]

A 20-week contemplative self-healing program significantly improved the quality of life (QOL) for 46 breast and gynecologic cancer survivors, as evidenced by a mean increase of 6.4 points on the FACIT-G scale.

Participants also experienced notable reductions in anxiety and distress, along with biological improvements such as lower resting heart rates and better cortisol levels, indicating enhanced emotional and physical well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a contemplative self-healing program on quality of life in women with breast and gynecologic cancers. Loizzo, JJ., Peterson, JC., Charlson, ME., et al.[2022]

A study involving 95 women with various cancer diagnoses showed that a self-hypnosis and self-care intervention significantly improved participants' quality of life, with 97.5% continuing to practice relaxation techniques after the program.

All components of the intervention, including group support and hypnosis exercises, were rated highly for their usefulness, indicating that a multicomponent approach may be effective in supporting cancer patients' self-care and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. Grégoire, C., Faymonville, ME., Vanhaudenhuyse, A., 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]

The Internet-Mindfulness-Based Stress Reduction (iMBSR) program significantly reduced anxiety in women with breast cancer, showing a medium effect size, although it did not significantly impact depression and stress levels.

iMBSR also led to significant improvements in body image and self-efficacy, with large effect sizes, indicating its potential as an effective mental health intervention during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of internet-delivered mindfulness-based stress reduction on mental health, self-efficacy, and body image among women with breast cancer during the COVID-19 pandemic. Chang, YC., Chiu, CF., Wang, CK., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduced distress and improved quality of life, mindfulness, and post-traumatic growth in a study of 50 women with breast and gynecologic cancer, with improvements maintained three months after the intervention.

Participants found the group-based MBCT program beneficial, indicating high acceptability, and the results suggest that MBCT could offer psychosocial benefits for women with cancer, although further randomized trials are needed for more definitive evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. Stafford, L., Foley, E., Judd, F., et al.[2022]

A pilot study involving mindfulness-based stress reduction (MBSR) showed significant reductions in anxiety among low-income ethnic minority women with abnormal Pap smears, despite a high dropout rate, with only 8 out of 51 participants completing the program.

Participants reported positive evaluations of the MBSR program, indicating its acceptability, but the study highlights challenges in recruitment and retention for this demographic, suggesting a need for improved strategies in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned: providing a mindfulness-based stress reduction program for low-income multiethnic women with abnormal pap smears. Abercrombie, PD., Zamora, A., Korn, AP.[2022]

The Gynecologic Survivorship Tool (GST) was successfully implemented for symptom management in women treated for gynecologic cancer, with a high completion rate of 71% from 1,405 patients over a year-long period.

The tool effectively identified common symptoms such as bowel problems and vaginal dryness, allowing healthcare teams to create targeted strategies for symptom relief, demonstrating its feasibility and efficiency in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes. Carter, J., Abu-Rustum, NR., Saban, S., et al.[2023]

Mind-body interventions like hypnosis and imagery/relaxation have been shown to effectively control pain and reduce anxiety in cancer patients, enhancing their overall treatment experience.

Yoga and meditation are supported by randomized controlled trials for improving quality of life, mood, and sleep in cancer patients, highlighting the importance of these therapies in managing the emotional and physical challenges of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. Carlson, LE., Bultz, BD.[2021]

This study aims to explore the feasibility of combining mindfulness and exercise interventions to manage cancer-related fatigue in women with gynecological cancer, using a randomized control trial design over 8 weeks with self-reported questionnaires.

The trial will assess not only the effectiveness of these combined interventions on fatigue, sleep, mood, and quality of life but also the feasibility of delivering them through a mobile application, focusing on recruitment, adherence, and participant perspectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of mindfulness alone compared to exercise and mindfulness on fatigue in women with gynaecology cancer (GEMS): Protocol for a randomised feasibility trial. McCloy, K., Hughes, C., Dunwoody, L., et al.[2023]

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Mindfulness in Endometrial and Cervical Cancer (MECCA)

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