Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate the effect of a brief educational program on colorectal cancer knowledge acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing visual/written educational material with and without mindfulness training to the standard of care.
II. To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education.
III. To determine the joint effect of colorectal cancer education delivered to both the patient and a caregiver on the overall colorectal cancer knowledge.
SECONDARY OBJECTIVES:
I. To examine the relative changes in psychobiological variables (stress, anxiety, depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in the 3 arms of the clinical trials.
II. To measure changes in salivary cortisol levels as an indicator of acute stress reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60 min) during active chemotherapy (T1).
III. To determine the moderating effect of baseline peripheral levels of inflammation (interleukin-1 [IL-1], IL-6, c-reactive protein [CRP] and tumor necrosis factor alpha [TNFa]) on the trajectory of salivary cortisol reactivity.
OUTLINE: Patients and caregivers are randomized to 1 of 3 groups.
GROUP I: Patients and caregivers receive standard of care.
GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90033
- USC Norris Comprehensive Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient diagnosed with colorectal cancer
- Patients with at least one more chemotherapy appointment at the time of enrollment
- if patients have a caregiver, patients should agree to bring a caregiver to one of their hospital visits or have the caregiver schedule a separate study visit
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Illiterate participants
- Deaf participants
- Participants that do not read speak or understand either Spanish or English
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Group I (standard of care)
Patients and caregivers receive standard of care.
|
|
|
実験的：Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
|
相関研究
補助研究
Watch an educational video
他の名前：
Watch mindfulness exercise video and/or educational video
|
|
実験的：Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
|
相関研究
補助研究
Watch an educational video
他の名前：
Watch mindfulness exercise video and/or educational video
Watch a mindfulness exercise video
他の名前：
|
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 |
|---|---|---|
|
Change in self-reported stress levels assessed using pre- and post-test assessments
時間枠：Baseline to up to 60 minutes
|
The intervention effects will be examined using multi-level modeling (MLM).
These analyses will include chi-square, t-tests, and one way analyses of variance (ANOVAs).
|
Baseline to up to 60 minutes
|
|
Change in colorectal cancer knowledge assessed using pre- and post-test assessments
時間枠：Baseline to up to 60 minutes
|
The intervention effects will be examined using multi-level modeling (MLM).
These analyses will include chi-square, t-tests, and one way ANOVAs.
|
Baseline to up to 60 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in salivary cortisol levels using chemiluminescence immunoassay
時間枠：Baseline to up 60 minutes
|
Cortisol slopes will be calculated with two distinct areas under the curve analyses using the trapezoid formula as outlined by Pruessner 2003.
Data values will be entered into a two factor (group by time) multilevel MIXED linear regression model to calculate differences between the three groups.
A Scheffe post hoc test will be employed to determine the direction of the differences between the groups.
|
Baseline to up 60 minutes
|
協力者と研究者
捜査官
- 主任研究者：Jane Figueiredo、University of Southern California
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 3C-13-6 (その他の識別子：USC Norris Comprehensive Cancer Center)
- P30CA014089 (米国 NIH グラント/契約)
- NCI-2014-00164 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- R01CA155101 (米国 NIH グラント/契約)
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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