Stage III Gynecologic CancerNCT04072406
A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
A study testing Mindfulness meditation in people with Stage III Gynecologic Cancer and Stage IV Gynecologic Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage III Gynecologic Cancer, Stage IV Gynecologic Cancer
- What is being tested?
- Mindfulness meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 10 Apr 2020
- 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
- Must be ≥ 18 years old
- Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other)
- Be native English speakers
- Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment;
- Not currently be practicing weekly meditation
- Be willing to create (or already have) an email address
- Have access to internet via a personal electronic device (or be willing to borrow an internet-enabled tablet from the study team).
Who cannot join
- <18 years old
- Distress Thermometer ratings ≤ 3
- Non-native English speakers
- Individuals with severe depression, and individuals who are having suicidal thoughts.
- Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already)
- Individuals who are currently practicing weekly meditation
- Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol IRB#: 201511102 (chemoresistance) or IRB# 201804169 (Cytokine-induced depression).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.
- Being tested
- Mindfulness meditation, Usual care packet
- Keywords
- mindfulness, meditation, behavioral treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationOther
Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team.
Usual care packetOther
Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Usual Care | Active comparator | * Participants assigned to usual care will receive a packet of instructions with information about how to complete weekly surveys via a link that will be emailed to them
* Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later Receives: Other: Usual care packet |
| Arm II: Mindfulness Meditation | Experimental | * Participants will listen to mindfulness meditations daily over the course of three weeks.
* Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later Receives: Other: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
-On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe).
Measured: From Baseline to week 3
Secondary outcomes (9)
Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer
-Patients rate distress on a scale from 0 (no distress) to 10 (extreme distress).
Measured: From Baseline to week 3
Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS)
-On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe).
Measured: From Baseline to week 3
Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
-includes 9 items to measure the severity of fatigue-related symptoms on a scale from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Items include ratings of fatigue at three time points: fatigue when it is at its "worst," fatigue when it is at its "usual" level, and fatigue as it is experienced "now," in the moment.
Measured: From Baseline to week 3
Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised
-The Edmonton Symptoms Assessment Scale Revised is a 10-item scale that measures severity of 10 physical and psychological symptoms (e.g., nausea, drowsiness, tiredness, anxiety) on a scale from 0 (e.g., no nausea) to 10 (e.g., worst possible nausea).
Measured: From Baseline to week 3
Change in emotion regulation as measured by the Emotion Regulation Questionnaire
-measures two emotion regulation strategies, cognitive reappraisal and expressive suppression. Respondents rate 10 items about these strategies on a scale from 1 (strongly disagree) to 7 (strongly agree).
Measured: From Baseline to week 3
Change in coping as measured by the Cognitive Emotion Regulation Questionnaire
-Will assess 20 items from four subscales (acceptance, rumination, positive reappraisal, putting into perspective, and self-blame)
Measured: From Baseline to week 3
Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire
-Assesses observing, describing, acting with awareness, non-judging, and non-reactivity. Participants rate 15 items on a scale from 1 (never or very rarely true) to 5 (very often or always true).
Measured: From Baseline to week 3
Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale
-20-item scale that measures overall compassion for the self. The items are divided into five subscales that correspond to the five components of self-compassion. Items are rated from 1 (not at all true) to 5 (always true).
Measured: From Baseline to week 3
Change in perceived stress as measured by the Perceived Stress Scale
-10-item measure of globally perceived stress. The measure invites participants to retrospectively report their feelings and thoughts about various topics during the last month, including "how often [you] have felt upset because of something that happened unexpectedly," "how often [you] have felt that things were going your way," and "how often [you] could not cope with all the things that you had to do." Participants rate each item on a scale of 0 (Never) to 5 (Very Often), and a higher score indicates greater stress.
Measured: From Baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Jul 2019
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University Department of Psychological and Brain Sciences
- Responsible party
- Sponsor
- Investigators
- Brian Carpenter, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072406
- Sponsor's protocol ID
- 201905188
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2019
- Last updated
- 30 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
- ClinicalTrials.gov ID
- NCT04072406
- Acronym / sponsor ID
- 201905188
- Keywords
- mindfulness, meditation, behavioral treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Washington University Department of Psychological and Brain Sciences
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 28 Aug 2019 (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.
The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Usual Care | Active comparator | Other: Usual care packet* Participants assigned to usual care will receive a packet of instructions with information about how to complete weekly surveys via a link that will be emailed to them * Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later |
| Arm II: Mindfulness Meditation | Experimental | Other: Mindfulness meditation* Participants will listen to mindfulness meditations daily over the course of three weeks. * Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later |
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)
- Must be ≥ 18 years old
- Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other)
- Be native English speakers
- Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment;
- Not currently be practicing weekly meditation
Key exclusion criteria (7 listed)
- <18 years old
- Distress Thermometer ratings ≤ 3
- Non-native English speakers
- Individuals with severe depression, and individuals who are having suicidal thoughts.
- Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already)
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 meditationParticipants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team. | Other | Arm II: Mindfulness Meditation |
| Usual care packetParticipants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team. | Other | Arm I: Usual Care |
Primary outcome
Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: From Baseline to week 3
-On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe).
9 secondary outcomes
Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer
Time frame: From Baseline to week 3
Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: From Baseline to week 3
Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Time frame: From Baseline to week 3
Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised
Time frame: From Baseline to week 3
Change in emotion regulation as measured by the Emotion Regulation Questionnaire
Time frame: From Baseline to week 3
Change in coping as measured by the Cognitive Emotion Regulation Questionnaire
Time frame: From Baseline to week 3
Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire
Time frame: From Baseline to week 3
Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale
Time frame: From Baseline to week 3
Change in perceived stress as measured by the Perceived Stress Scale
Time frame: From Baseline to week 3
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Brian Carpenter, Ph.D. principal investigator
Washington University School of Medicine
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 meditation in people with Stage III Gynecologic Cancer and Stage IV Gynecologic Cancer, run by Washington University School of Medicine 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 7 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: stopped early, as of the sponsor's last update on 30 Dec 2024. 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 was stopped early (reason given: Covid-19). Results are not available in the source record.
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 symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) (time frame: From Baseline to week 3). 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 Dec 2024.