Female Reproductive System NeoplasmNCT03379376
EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
A study testing Questionnaire Administration and Supportive Care in people with Female Reproductive System Neoplasm and Malignant Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm
- What is being tested?
- Questionnaire Administration and Supportive Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Cognitively able to complete assessments as judged by the study team
- Able to understand, read and write English
Who cannot join
- Have schizophrenia or any other psychotic disorder
- Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.
Read the detailed description
PRIMARY OBJECTIVES:
- To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.
OUTLINE:
Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.
After completion of study, participants are followed up at 4 weeks from surgery.
- Conditions
- Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Ovarian Neoplasm, Suspicious for Malignancy
- Being tested
- Questionnaire Administration, Supportive Care
- Medical subject headings
- Genital Neoplasms, Female, Uterine Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Receive questionnaire
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Undergo eHealth mindful moving and breathing
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (eMMB) | Experimental | Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Receives: Other: Questionnaire Administration; Procedure: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Confident in the Use of EHealth Format
This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
Measured: Up to 4 weeks
Secondary outcomes (4)
Number of Participants Recruited and Completed All Assessments
Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.
Measured: Up to 4 weeks
Number of Participants That Adhered to Study Interventions
To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:
Measured: Up to 4 weeks
Number of Participants Reporting Adverse Events
Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.
Measured: Up to 4 weeks
Percentage of Participants Completing 4-week Visits
To be assessed by calculating the percent of participants who complete the 4-week visit.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start5 Apr 2018
- Primary completion15 Oct 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Sohl, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379376
- Sponsor's protocol ID
- IRB00046462
- Other IDs
- NCI-2018-00584, CCCWFU 04517, P30CA012197
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2017
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II
- ClinicalTrials.gov ID
- NCT03379376
- Acronym / sponsor ID
- IRB00046462
- Conditions
- Female Reproductive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Ovarian Neoplasm, Suspicious for Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.
Detailed description
PRIMARY OBJECTIVES:
- To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.
OUTLINE:
Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.
After completion of study, participants are followed up at 4 weeks from surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (eMMB) | Experimental | Other: Questionnaire Administration, Procedure: Supportive CareParticipants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Cognitively able to complete assessments as judged by the study team
- Able to understand, read and write English
Key exclusion criteria (2 listed)
- Have schizophrenia or any other psychotic disorder
- Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome
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 |
|---|---|---|
| Questionnaire AdministrationReceive questionnaire | Other | Supportive Care (eMMB) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveUndergo eHealth mindful moving and breathing | Procedure or surgery | Supportive Care (eMMB) |
Primary outcome
Number of Participants Confident in the Use of EHealth Format
Time frame: Up to 4 weeks
This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
4 secondary outcomes
Number of Participants Recruited and Completed All Assessments
Time frame: Up to 4 weeks
Number of Participants That Adhered to Study Interventions
Time frame: Up to 4 weeks
Number of Participants Reporting Adverse Events
Time frame: Up to 4 weeks
Percentage of Participants Completing 4-week Visits
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephanie Sohl principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Supportive Care in people with Female Reproductive System Neoplasm and Malignant Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences 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 4 inclusion and 2 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 30 Dec 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?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Confident in the Use of EHealth Format (time frame: Up to 4 weeks). 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 2019; AzTrials last refreshed its copy on 7 Nov 2026.