栄養とトレーニングにおける正確な腫瘍学介入 (OnPoint) (OnPoint)
The purpose of this study is to see if survivors of breast, prostate, colorectal or lymphoma cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Grey Freylersythe, BS
- 電話番号：305-243-9832
- メール：g.freylersythe@med.miami.edu
研究連絡先のバックアップ
- 名前：Tracy Crane, PhD, RDN
- 電話番号：305-243-8255
- メール：tecrane@med.miami.edu
研究場所
-
-
Florida
-
Miami、Florida、アメリカ、33136
- 募集
- University of Miami
-
コンタクト：
- Grey Freylersythe, BS
- 電話番号：(305) 243-9832
- メール：g.freylersythe@med.miami.edu
-
コンタクト：
- Tracy Crane, PhD, RDN
- 電話番号：(305) 243-8255
- メール：tecrane@med.miami.edu
-
主任研究者：
- Tracy Crane, PhD, RDN
-
-
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:
Inclusion Criteria - Healthcare Providers
- Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
- Utilize the electronic medical record for patient documentation on a regular basis
- Willing to complete a 30-60-minute interview
Inclusion Criteria - Patients
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read/understand English or Spanish
- Diagnosis of breast, prostate, colorectal or lymphoma cancer, 6 months post completion of primary treatment, with no evidence of primary disease
- Approval from treating oncologist, confirmed via email or in writing
- Fail to meet at least one of the American Cancer Society guidelines: engaging in >150 minutes of moderate-to-vigorous physical activity per week for the prior month or consuming at least 3 cups of vegetables and 2 cups of fruit per day over the past month.
- Internet access on a smart phone, tablet, or computer
- Agree to be randomly assigned to any study group
Exclusion Criteria:
- Less than 18 years of age
- Unable to provide consent
- Unable to read/understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Blank
- Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
- Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
- History of dementia or major psychiatric disease which would interfere with study participation
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) score of >2
- Severe lymphedema as determined by physician
- Receiving physical therapy treatment
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Low Complexity Group
Participants in this group will receive the low complexity intervention for up to eight (8) weeks. |
Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. |
|
実験的：Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks. |
Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. The nutrition course will follow a combined asynchronous and synchronous approach. The asynchronous component will consist of a pre-recorded session covering educational nutrition content, which will be made available to participants for self-paced learning. This will be followed by a synchronous, 30-60 minute live group education class on nutrition information for cancer survivors, held once per week. The Physical Activity Program will be held virtually or in-person. This will be a 1-hour biweekly group education class on aerobic and resistance exercise recommendations for cancer survivors. |
|
実験的：High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks. |
Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. Participants will be referred to weekly one on one nutrition counseling sessions with a Registered Dietitian. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual. Participants will be referred to weekly one on one exercise training sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual |
|
介入なし：Control Group
Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 18 weeks. |
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 Survivors Who Agree to Participate
時間枠：Up to 8 Weeks
|
Percentage of survivors who agree to participate will be reported as ≥ 50%. |
Up to 8 Weeks
|
|
Percentage of Interventions Sessions Completed
時間枠：Up to 8 Weeks
|
Percentage of intervention sessions completed will be reported as ≥ 80%. |
Up to 8 Weeks
|
|
Percentage of Participants Satisfied with the Intervention
時間枠：Up to 8 Weeks
|
Report of 80% satisfaction will be determined as satisfaction with intervention components. |
Up to 8 Weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tracy Crane, PhD, RDN、University of Miami
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 20230533
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?
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
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