Gynecologic CancerMECCANCT04512144
Mindfulness in Endometrial and Cervical Cancer
A study testing Headspace Smartphone Application in people with Gynecologic Cancer and Endometrial Cancer, run by St. Louis University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Endometrial Cancer, Cervical Cancer
- What is being tested?
- Headspace Smartphone Application
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2020to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
- Access to a smartphone
Who cannot join
- Non-English speaking
- No access to smartphone
- Current use of Headspace application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Saint Louis University
St Louis, Missouri, 63104
Shannon Grabosch, MD, 314-781-8605 ext. 1, shannon.grabosch@health.slu.edu
About this study
Official title: Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)
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.
Read the detailed description
A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.
Even short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.
A patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.
- Being tested
- Headspace Smartphone Application
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headspace Smartphone ApplicationBehavioural
Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Headspace Smartphone Application |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Usage-Endometrial cancer
The amount of opiates used during the acute (30 day) recovery after surgery for endometrial cancer or acute treatment with chemoradiation for cervical cancer will be recorded.
Measured: Enrollment to 30 days post op for endometrial cancer.
Opiate Usage-Cervical Cancer
The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
Measured: Enrollment to 6 weeks post treatment for cervical cancer.
Secondary outcomes (5)
Five Facet Mindfulness Questionnaire
Patients will be asked to complete a Five Facet Mindfulness Questionnaire form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
Measured: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Functional Assessment of Cancer Therapy-General
Patients will be asked to complete a Functional Assessment of Cancer Therapy-General form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
Measured: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Complication Rates
Surgical or treatment complications will be monitored in each group.
Measured: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Patient satisfaction
Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.
Measured: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Compliance
The number of Headspace sessions utilized by patients in the intervention group will be recorded.
Measured: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start25 Jul 2020
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Grabosch, MD, St. Louis University
- Investigators
- Shannon Grabosch, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512144
- Sponsor's protocol ID
- 30780
- Acronym
- MECCA
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)
- ClinicalTrials.gov ID
- NCT04512144
- Acronym / sponsor ID
- MECCA / 30780
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.
Even short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.
A patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Headspace Smartphone ApplicationPatients 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. |
| Control | No 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 may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
- Access to a smartphone
Key exclusion criteria (3 listed)
- Non-English speaking
- No access to smartphone
- Current use of Headspace application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headspace Smartphone ApplicationHeadspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies. | Behavioural | Intervention |
Primary outcome
Opiate Usage-Endometrial cancer
Time frame: Enrollment to 30 days post op for endometrial cancer.
The amount of opiates used during the acute (30 day) recovery after surgery for endometrial cancer or acute treatment with chemoradiation for cervical cancer will be recorded.
Opiate Usage-Cervical Cancer
Time frame: Enrollment to 6 weeks post treatment for cervical cancer.
The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
5 secondary outcomes
Five Facet Mindfulness Questionnaire
Time frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Functional Assessment of Cancer Therapy-General
Time frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Complication Rates
Time frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Patient satisfaction
Time frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Compliance
Time frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Grabosch, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headspace Smartphone Application in people with Gynecologic Cancer and Endometrial Cancer, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Grabosch, MD (3147818605 ext. 1, shannon.grabosch@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate Usage-Endometrial cancer (time frame: Enrollment to 30 days post op for endometrial cancer.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.