Mindfulness App for Gynecologic Cancers

(MECCA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Shannon Grabosch, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: St. Louis University

Disqualifiers: Non-English speaking, No smartphone, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated 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 data supports the effectiveness of the treatment Headspace Mindfulness App for gynecologic cancers?

Research shows that mindfulness and meditation, like those offered by the Headspace app, can help reduce stress and improve mood and quality of life for cancer patients. A study on mobile app-delivered mindfulness training found it effective in improving quality of life among women with breast cancer, which may suggest similar benefits for those with gynecologic cancers. ^{1 2 3 4 5}

Is the Headspace Mindfulness App safe for use in humans?

The research on mindfulness-based interventions, including those similar to the Headspace App, suggests they are generally safe for humans. Studies have shown that mindfulness can improve quality of life and reduce stress-related symptoms in cancer patients without significant safety concerns. ^{6 7 8 9 10}

How does the mindfulness app treatment for gynecologic cancers differ from other treatments?

The mindfulness app treatment is unique because it uses a mobile app to deliver mindfulness training, which can improve quality of life and mental health for women with gynecologic cancers. Unlike traditional treatments that focus on physical symptoms, this approach targets psychological well-being and can be accessed conveniently from home. ^{2 3 11 12 13}

Research Team

Shannon Grabosch, MD

Principal Investigator

St. Louis University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Headspace Smartphone Application (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Laura Simpson

St. Louis University

Chief Medical Officer since 2023

PhD in Molecular and Cellular Biology from Tulane University

Dr. Keith Vendola

St. Louis University

Chief Executive Officer since 2023

PhD in Molecular Biology from Washington University in St. Louis

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

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

A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. [2023]

2. 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]

3. Germany 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. [2022]

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

Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes. [2023]

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

Mind-body interventions in oncology. [2021]

6. England 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? [2022]

7. 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]

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

A Mindfulness-Based Lifestyle Intervention for Obese, Inactive Endometrial Cancer Survivors: A Feasibility Study. [2023]

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

The effect of a contemplative self-healing program on quality of life in women with breast and gynecologic cancers. [2022]

10. United States 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. [2023]

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

Lessons learned: providing a mindfulness-based stress reduction program for low-income multiethnic women with abnormal pap smears. [2022]

12. United States 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. [2022]

13. Switzerland 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. [2022]