Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
2021年11月5日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
補助研究
Given information about mindful movement and breathing
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|
アクティブコンパレータ：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.
|
補助研究
Receive caring attention phone call
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Retained in the Study
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
時間枠：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
時間枠：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
時間枠：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
|
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Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 4 weeks
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Will describe any adverse events reported as frequencies.
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Up to 4 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年12月7日
一次修了 (実際)
2020年4月9日
研究の完了 (実際)
2020年4月9日
試験登録日
最初に提出
2018年8月31日
QC基準を満たした最初の提出物
2018年9月19日
最初の投稿 (実際)
2018年9月24日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月8日
QC基準を満たした最後の更新が送信されました
2021年11月5日
最終確認日
2021年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00052655
- P30CA012197 (米国 NIH グラント/契約)
- NCI-2018-01801 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- CCCWFU 97218 (その他の識別子：Wake Forest University Health Sciences)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。