Ovarian NeoplasmNCT03681405

Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

A study testing Informational Intervention, Questionnaire Administration and Telephone-Based Intervention in people with Ovarian Neoplasm and Uterine Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Neoplasm, Uterine Neoplasm
What is being tested?: Informational Intervention, Questionnaire Administration and Telephone-Based Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 7 Dec 2018to 9 Apr 2020
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 suspected malignancy.
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

Other trials in United States

About this study

Official title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

Read the detailed description

PRIMARY OBJECTIVES:

To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (MINDFUL MOVEMENT AND BREATHING [eMMB]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL [AC]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Conditions: Ovarian Neoplasm, Uterine Neoplasm
Being tested: Informational Intervention, Questionnaire Administration, Telephone-Based Intervention
Medical subject headings: Ovarian Neoplasms, Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Informational InterventionOther
Given information about mindful movement and breathing
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive caring attention phone call

Study groups in NCT03681405
Study group	Role	What they receive
Group I (eMMB)	Experimental	Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Receives: Other: Informational Intervention; Other: Questionnaire Administration
Group II (AC)	Active comparator	Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Receives: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Retained in the Study
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.
Measured: Up to 2 weeks
Percentage of Participants That Were Adhered to the Intervention
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.
Measured: Up to 5 weeks

Secondary outcomes (7)

Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. A change in pain intensity between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)
Measured: Baseline, 2 weeks and 4 weeks
Change in Affective Dimension of Pain
The affective dimension of pain will be assessed with one item on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). A higher score represent a higher affective dimension of pain for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Measured: Baseline, 2 weeks and 4 weeks
Change in Pain Interference Per PROMIS Measure
Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject. Score range is 0-100 with a higher score representing greater pain interference for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Measured: Baseline, 2 weeks and 4 weeks
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with higher scores representing a greater sleep disturbance for participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Measured: Baseline, 2 weeks and 4 weeks
Change in Psychological Distress Per PROMIS Depression
Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with the higher score representing greater depression in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Measured: Baseline, 2 weeks and 4 weeks
Change in Psychological Distress Per PROMIS Anxiety
Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with a higher score presenting a greater level of anxiety in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Measured: Baseline, 2 weeks and 4 weeks
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Will describe any adverse events reported as frequencies.
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.

7 Dec 20189 Apr 2020

First posted24 Sep 2018
Study start7 Dec 2018
Primary completion9 Apr 2020
Study completion9 Apr 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ovarian NeoplasmStudies 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: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03681405
Sponsor's protocol ID: IRB00052655
Other IDs: NCI-2018-01801, CCCWFU 97218, P30CA012197
Status last verified: Nov 2021
First submitted: 31 Aug 2018
Last updated: 8 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sohl SJ, Strahley AE, Tooze JA, Levine BJ, Kelly MG, Wheeler A, Evans S, Danhauer SC. Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes. J Psychosoc Oncol. 2024;42(2):223-241. doi: 10.1080/07347332.2023.2236083. Epub 2023 Jul 18.
PubMed 37462260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
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All Ovarian Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
ClinicalTrials.gov ID: NCT03681405
Acronym / sponsor ID: IRB00052655
Conditions: Ovarian Neoplasm, Uterine Neoplasm
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 7 Dec 2018 (actual)
Primary completion: 9 Apr 2020 (actual)
Study completion: 9 Apr 2020 (actual)
First posted: 24 Sep 2018 (actual)
Results: Posted 24 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group I (eMMB)	Experimental	Other: Informational Intervention, Other: Questionnaire AdministrationParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.
Group II (AC)	Active comparator	Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

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 suspected malignancy.
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
Informational InterventionGiven information about mindful movement and breathing	Other	Group I (eMMB)
Questionnaire AdministrationAncillary studies	Other	Group I (eMMB), Group II (AC)
Telephone-Based InterventionReceive caring attention phone call	Behavioural	Group II (AC)

Primary outcome

Percentage of Participants Retained in the Study
Time frame: Up to 2 weeks
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.
Percentage of Participants That Were Adhered to the Intervention
Time frame: Up to 5 weeks
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.

7 secondary outcomes

Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline, 2 weeks and 4 weeks
Change in Affective Dimension of Pain
Time frame: Baseline, 2 weeks and 4 weeks
Change in Pain Interference Per PROMIS Measure
Time frame: Baseline, 2 weeks and 4 weeks
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Time frame: Baseline, 2 weeks and 4 weeks
Change in Psychological Distress Per PROMIS Depression
Time frame: Baseline, 2 weeks and 4 weeks
Change in Psychological Distress Per PROMIS Anxiety
Time frame: Baseline, 2 weeks and 4 weeks
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 4 weeks

Results and safety

Results posted to the registry on 24 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I eHealth Mindful Movement and Breathing (eMMB)	14	13
Group II Attention Control (AC)	17	17

Primary outcome: Percentage of Participants Retained in the Study

Time frame: Up to 2 weeks. Number (95% Confidence Interval). Unit: percentage of participants retained

Measure	Group I (eMMB) n = 14	Group II (AC) n = 17
Value	78.6 (49.2 to 95.4)	82.4 (56.6 to 96.2)

Population analysed: Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of retention to be analyzed for the study.

Primary outcome: Percentage of Participants That Were Adhered to the Intervention

Time frame: Up to 5 weeks. Number (95% Confidence Interval). Unit: percentage of participants adhered

Measure	Group I (eMMB) n = 14	Group II (AC) n = 17
Value	85.7 (57.2 to 98.2)	70.6 (44.1 to 89.7)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Four weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (eMMB)	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Group II (AC)	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37462260Sohl SJ, Strahley AE, Tooze JA, Levine BJ, Kelly MG, Wheeler A, Evans S, Danhauer SC. Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes. J Psychosoc Oncol. 2024;42(2):223-241. doi: 10.1080/07347332.2023.2236083. Epub 2023 Jul 18.

Related trials for Ovarian Neoplasm

Active, not recruitingPhase 1/2
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RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
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RecruitingObservational study
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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?

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 8 Nov 2021. 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 24 Jun 2021). 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?

Percentage of Participants Retained in the Study (time frame: Up to 2 weeks). 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?

On the ClinicalTrials.gov record for NCT03681405, which also lists 1 linked publication.

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 8 Nov 2021.