Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
5. november 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hjælpestudier
Given information about mindful movement and breathing
|
|
Aktiv komparator: 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.
|
Hjælpestudier
Receive caring attention phone call
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Retained in the Study
Tidsramme: 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.
|
Up to 2 weeks
|
|
Percentage of Participants That Were Adhered to the Intervention
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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
|
|
Change in Affective Dimension of Pain
Tidsramme: 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
|
|
Change in Pain Interference Per PROMIS Measure
Tidsramme: 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.
|
Baseline, 2 weeks and 4 weeks
|
|
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Tidsramme: 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
|
|
Change in Psychological Distress Per PROMIS Depression
Tidsramme: 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
|
|
Change in Psychological Distress Per PROMIS Anxiety
Tidsramme: 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.
|
Baseline, 2 weeks and 4 weeks
|
|
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Tidsramme: Up to 4 weeks
|
Will describe any adverse events reported as frequencies.
|
Up to 4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. december 2018
Primær færdiggørelse (Faktiske)
9. april 2020
Studieafslutning (Faktiske)
9. april 2020
Datoer for studieregistrering
Først indsendt
31. august 2018
Først indsendt, der opfyldte QC-kriterier
19. september 2018
Først opslået (Faktiske)
24. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00052655
- P30CA012197 (U.S. NIH-bevilling/kontrakt)
- NCI-2018-01801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CCCWFU 97218 (Anden identifikator: Wake Forest University Health Sciences)
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