Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
5 november 2021 bijgewerkt door: Wake Forest University Health Sciences
Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
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 techniques, and may help improve participants' well-being after gynecological surgery.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To calculate recruitment, adherence, assessment completion, and retention rates.
SECONDARY OBJECTIVES:
I. 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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
31
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University Health Sciences
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group I (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.
|
Nevenstudies
Given information about mindful movement and breathing
|
|
Actieve vergelijker: Group II (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.
|
Nevenstudies
Receive caring attention phone call
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants Retained in the Study
Tijdsspanne: 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.
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Up to 2 weeks
|
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Percentage of Participants That Were Adhered to the Intervention
Tijdsspanne: 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.
|
Up to 5 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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) |
Baseline, 2 weeks and 4 weeks
|
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Change in Affective Dimension of Pain
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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.
|
Baseline, 2 weeks and 4 weeks
|
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Change in Pain Interference Per PROMIS Measure
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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.
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Baseline, 2 weeks and 4 weeks
|
|
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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.
|
Baseline, 2 weeks and 4 weeks
|
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Change in Psychological Distress Per PROMIS Depression
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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.
|
Baseline, 2 weeks and 4 weeks
|
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Change in Psychological Distress Per PROMIS Anxiety
Tijdsspanne: Baseline, 2 weeks and 4 weeks
|
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.
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Baseline, 2 weeks and 4 weeks
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Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Tijdsspanne: Up to 4 weeks
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Will describe any adverse events reported as frequencies.
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Up to 4 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 december 2018
Primaire voltooiing (Werkelijk)
9 april 2020
Studie voltooiing (Werkelijk)
9 april 2020
Studieregistratiedata
Eerst ingediend
31 augustus 2018
Eerst ingediend dat voldeed aan de QC-criteria
19 september 2018
Eerst geplaatst (Werkelijk)
24 september 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 november 2021
Laatste update ingediend die voldeed aan QC-criteria
5 november 2021
Laatst geverifieerd
1 november 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00052655
- P30CA012197 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2018-01801 (Register-ID: CTRP (Clinical Trial Reporting Program))
- CCCWFU 97218 (Andere identificatie: Wake Forest University Health Sciences)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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