AnxietyNCT02518308
Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
A study testing Mindfulness-Based Stress Reduction in people with Anxiety and Cancer Survivor, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Cancer Survivor, Cognitive Impairment
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2015to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
- Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- Expected to continue cancer care at UWCCC for the duration of the study.
Who cannot join
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
- Prisoner or incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina. Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness. This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
Read the detailed description
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
- Conditions
- Anxiety, Cancer Survivor, Cognitive Impairment, Depression, Distress, Fatigue
- Being tested
- Mindfulness-Based Stress Reduction
- Medical subject headings
- Anxiety Disorders, Cognitive Dysfunction, Depression, Fatigue, Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MBSR intervention) | Experimental | Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice. Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Arm II (control) | No intervention | Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
Measured by the 8-item anxiety subscale of the PROMIS scale.
Measured: Baseline to up to 5 months
Secondary outcomes (10)
Change in depression
Measured by PROMIS subscale for depression.
Measured: Baseline to up to 5 months
Change in fatigue
Measured by PROMIS subscale for fatigue.
Measured: Baseline to up to 5 months
Change in sleep disturbance
Measured by PROMIS subscale for sleep disturbance.
Measured: Baseline to up to 5 months
Change in sexual function
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
Measured: Baseline to up to 5 months
Change in existential/spiritual distress
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
Measured: Baseline to up to 5 months
Change in cognitive function
Measured by the NIH Toolbox Assessments
Measured: Baseline to up to 5 months
Change in cortisol levels
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Measured: Baseline to up to 5 months
Change in levels of pro-inflammatory cytokines
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Measured: Baseline to up to 5 months
Change in immune cell phenotypes
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Measured: Baseline to up to 5 months
Change in NK cell function
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Measured: Baseline to up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start18 Nov 2015
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Spencer, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518308
- Sponsor's protocol ID
- UW15000
- Other IDs
- 2015-0549, A532820, SMPH\OBSTET & GYNECOL\OB-GYN, NCI-2015-01263
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2015
- Last updated
- 15 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
- ClinicalTrials.gov ID
- NCT02518308
- Acronym / sponsor ID
- UW15000
- Conditions
- Anxiety, Cancer Survivor, Cognitive Impairment, Depression, Distress, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina. Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness. This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
Detailed description
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MBSR intervention) | Experimental | Behavioral: Mindfulness-Based Stress ReductionPatients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice. |
| Arm II (control) | No intervention | –Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
Key exclusion criteria (6 listed)
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRThe Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga. | Behavioural | Arm I (MBSR intervention) |
Primary outcome
Change in anxiety
Time frame: Baseline to up to 5 months
Measured by the 8-item anxiety subscale of the PROMIS scale.
10 secondary outcomes
Change in depression
Time frame: Baseline to up to 5 months
Change in fatigue
Time frame: Baseline to up to 5 months
Change in sleep disturbance
Time frame: Baseline to up to 5 months
Change in sexual function
Time frame: Baseline to up to 5 months
Change in existential/spiritual distress
Time frame: Baseline to up to 5 months
Change in cognitive function
Time frame: Baseline to up to 5 months
Change in cortisol levels
Time frame: Baseline to up to 5 months
Change in levels of pro-inflammatory cytokines
Time frame: Baseline to up to 5 months
Change in immune cell phenotypes
Time frame: Baseline to up to 5 months
Change in NK cell function
Time frame: Baseline to up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- University of Wisconsin Carbone Cancer Center Home PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ryan Spencer principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Anxiety and Cancer Survivor, run by University of Wisconsin, Madison 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 15 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: Baseline to up to 5 months). 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 15 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.