栄養不足に陥ったがん生存者の栄養ニーズに対処する
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
主な目的:
I. 介入の実現可能性と受け入れ可能性を判断する。
第二の目的:
I. 米国癌協会の栄養ガイドラインの順守に対する介入の効果を推定する。
II. 自己申告による食糧不安に対する介入の効果を推定する。
Ⅲ. 患者ナビゲーションコールの実現可能性を評価する。 IV. Instacart バウチャーの実現可能性を評価するため。
探索的な目的:
I. 研究終了後の半構造化面接を通じて介入の実現可能性を評価する。
概要:
患者には、がん生存者の栄養と身体活動に関する小冊子と、研究期間中 4 週間使用できる Instacart 食料品配達券 1 枚が渡されます。 患者はまた、栄養ガイドラインに従うことや Instacart で食料品を注文することについて支援を求める栄養ナビゲーションの電話を週に 1 回 (QW) 4 週間受けます。
研究介入の完了後、患者は28日間追跡調査されます。
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Bryan Le
- 電話番号:(415) 502-6313
- メール:bryankhuong.le@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California, San Francisco
-
San Francisco、California、アメリカ、94110
- Zuckerberg San Francisco General
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
包含基準:
- 年齢 > 18歳
- 悪性がんの診断(非黒色腫皮膚がんを除く)。
- スクリーニング時に積極的な治療を受けておらず、研究期間中に積極的な抗がん療法(手術、放射線、化学療法、免疫療法、標的療法など)を受ける予定がない。 ホルモン療法は乳がんまたは前立腺がんの患者に許可されています
- 大手術から少なくとも 6 週間が経過し、完全に回復している。
- 携帯電話を所有しており、テキスト メッセージを喜んで送受信できる。
- 英語を話す/読むことができる。
米国農務省 (USDA) の米国家庭食料安全保障調査に基づいて、食料不安を経験していると特定する、および/または国立衛生研究所 (NIH) が健康上のリスクがあると特定した集団に属していることを特定します。格差:
- NIHが定義する人種的または民族的少数派であると認識している(アメリカインディアンまたはアラスカ先住民、アジア人、黒人またはアフリカ系アメリカ人、ハワイ先住民または太平洋諸島系住民、ラテン系またはヒスパニック系)
- 性的またはジェンダー的に少数派のグループであると認識する。
- 世帯年収 < 連邦貧困定義の 200% 未満、および/または学歴 < 学士号。
- 田舎および/または貧困が続く地域(郵便番号に基づく)に住んでいます。
除外基準:
- 研究関連の手順または評価に対する禁忌。
- 研究期間中に計画された大規模な手術またはがんを対象とした治療。
- スクリーニング中および/または研究期間中に米国またはカナダ外に居住している(Instacart がカバーする地理的領域外)。
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:Supportive Care (Instacart voucher, nutrition navigation)
Participants receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study.
Participants also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks.
|
がんサバイバーのための栄養と身体活動に関する小冊子を受け取る
Instacartの食料品配達クーポンを受け取る
他の名前:
栄養ナビの電話を受ける
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Median Score on the Feasibility of Intervention Measure (FIM) Survey
時間枠:At 4 week assessment, 1 day
|
The FIM is a four-item measure of implementation that assesses participants perceived feasibility of the intervention.
Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree).
A total score is calculated by averaging responses.
Total score values range from 1 to 5 with higher values representing a greater feasibility.
The intervention will be determined feasible if the overall median score is >= 4. The median and full range of the FIM scores will be reported.
|
At 4 week assessment, 1 day
|
|
Median Score on the Acceptability of Intervention Measure (AIM) Survey
時間枠:At 4 week assessment, 1 day
|
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention.
Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree).
A total score is calculated by averaging responses.
Total score values range from 1 to 5 with higher scores indicating a greater acceptability of the intervention.
The intervention will be determined acceptable if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
|
At 4 week assessment, 1 day
|
|
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
時間枠:At 4 week assessment, 1 day
|
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention.
Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree).
A total score is calculated by averaging responses.
Total score values range from 1 to 5 with higher scores indicating a higher agreement with the appropriateness of the intervention.
The intervention will be determined appropriate if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
|
At 4 week assessment, 1 day
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
時間枠:Up to 4 weeks
|
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits.
This brief screener asks participants to report on dietary intake in the past month.
Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat.
The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/).
A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist.
Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
|
Up to 4 weeks
|
|
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
時間枠:Up to 4 weeks
|
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits.
This brief screener asks participants to report on dietary intake in the past month.
Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat.
The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/).
A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist.
Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
|
Up to 4 weeks
|
|
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
時間枠:Up to 4 weeks
|
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits.
This brief screener asks participants to report on dietary intake in the past month.
Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat.
The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/).
A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist.
Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
|
Up to 4 weeks
|
|
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
時間枠:Up to 4 weeks
|
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits.
This brief screener asks participants to report on dietary intake in the past month.
Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat.
The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/).
A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist.
Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
|
Up to 4 weeks
|
|
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
時間枠:Up to 4 weeks
|
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits.
This brief screener asks participants to report on dietary intake in the past month.
Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat.
The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/).
A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist.
Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range will be used to describe the change of overall adherence over time.
|
Up to 4 weeks
|
|
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
時間枠:Up to 4 weeks
|
The United States Department of Agriculture Food Insecurity Questionnaire consists of 6 items that address various aspect of food security.
Responses of "often" or "sometimes" and "yes" are coded as affirmative.
Responses of "almost every month" and "some months but not every month" are coded as affirmative.
The sum of affirmative responses to the six questions in the module is the household's raw score on the scale.
Food security status is assigned as follows: Raw score 0-1 = High or marginal food security (raw score=1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score of 0 on the six-item scale), Raw scores of 2-4=Low food security, Raw scores 5-6=Very low food security.
The mean change in raw score over time will be reported along with the standard deviation.
|
Up to 4 weeks
|
|
Proportion of Participants Who Participated in Navigation Calls
時間枠:Up to 4 weeks
|
The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported.
|
Up to 4 weeks
|
|
Proportion of Participants Using Instacart Vouchers
時間枠:Up to 4 weeks
|
The proportion of participants who utilized the Instacart vouchers during the course of the study will be reported.
|
Up to 4 weeks
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Erin Van Blarigan, ScD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 24806
- NCI-2024-07163 (レジストリ識別子:NCI Clinical Trials Reporting Program (CTRP))
- U54CA280811 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
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。