- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03681405
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Health Sciences
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Studi accessori
Given information about mindful movement and breathing
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Comparatore attivo: 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.
|
Studi accessori
Receive caring attention phone call
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants Retained in the Study
Lasso di tempo: 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
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Lasso di tempo: Baseline, 2 weeks and 4 weeks
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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
Lasso di tempo: 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.
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Baseline, 2 weeks and 4 weeks
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Change in Pain Interference Per PROMIS Measure
Lasso di tempo: Baseline, 2 weeks and 4 weeks
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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
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Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Lasso di tempo: 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.
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Baseline, 2 weeks and 4 weeks
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Change in Psychological Distress Per PROMIS Depression
Lasso di tempo: 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.
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Baseline, 2 weeks and 4 weeks
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Change in Psychological Distress Per PROMIS Anxiety
Lasso di tempo: Baseline, 2 weeks and 4 weeks
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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
Lasso di tempo: Up to 4 weeks
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Will describe any adverse events reported as frequencies.
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Up to 4 weeks
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00052655
- P30CA012197 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2018-01801 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- CCCWFU 97218 (Altro identificatore: Wake Forest University Health Sciences)
Informazioni su farmaci e dispositivi, documenti di studio
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