Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners
Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study
Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new cases estimated for 2015. Prostate cancer patients often live with uncomfortable side effects of treatment, such as a decrease in bone health, weight gain, and challenges to their interpersonal relationships. Nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for prostate cancer survivors and their partners.
The objectives are to assess the feasibility of the intervention, specifically:
- Accrual, retention and adherence, and participant satisfaction
- Candidate measures for primary outcomes in future studies
The intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.
調査の概要
詳細な説明
Prostate cancer (PCa) is the most commonly-diagnosed invasive cancer in Canada, with 24,000 new cases predicted for 2015. The large majority of men (96%) will survive five or more years post-diagnosis. However, many PCa survivors live with side effects of the disease and treatment and may develop chronic conditions due to aging and/or cancer therapy. The PCa-related side effects can also impact men's interpersonal relationships. Effective interventions to promote health and well-being for PCa survivors are urgently needed.
Evidence shows that nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Furthermore, all PCa-related interventions reported thus far are limited in one important way: they focus only on the patient/survivor. Yet, the impact of prostate cancer extends to the spouse as well. When it comes to lifestyle interventions, responsibility for health behaviours and food preparation typically falls on the wife, particularly in today's cohort of PCa patients. As such, engaging the partner is crucial to ensure success for the survivor, and provide benefits for the wife as well.
Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for PCa survivors and their partners.
The objectives are to assess the feasibility of the intervention, specifically:
- Accrual, retention and adherence, and participant satisfaction
- Candidate measures for primary outcomes in future studies
The study draws on Interdependence Theory and features of successful cooking class intervention research in other populations. Specifically, it uses hands-on cooking experience, combined with increased cooking skills and nutrition knowledge to build skills and self-efficacy; to be culturally appropriate and use simple affordable ingredients; and to involve the spouses.
The dietary intervention will be offered to a total of 24 couples (48 individuals). The intervention includes 6 cooking and nutrition-related classes, that are held weekly in a university classroom kitchen with interactive demo and cooking components. Classes focus on learning through preparing theme-based recipes, with themes organized around prostate health.
Feasibility outcomes are assessed throughout. Questionnaire-based outcomes are assessed pre- and post-intervention, anthropometric outcomes at first and last intervention session.
The main intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.
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
-
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British Columbia
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Vancouver、British Columbia、カナダ、V6T1Z3
- University of British Columbia
-
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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 for Men with Prostate Cancer:
- A man
- Have a diagnosis of prostate cancer
- 18 years or older
- Are living with a wife or common-law partner
- Can read and understand English
- Have a desire to participate in a cooking class study with wife/partner
Exclusion Criteria for Men with Prostate Cancer:
• Are on a strict diet, such as gluten-free diet
Inclusion Criteria for Partners:
- Are a female
- Are living with a husband or common-law partner who has been diagnosed with prostate cancer
- Are 18 years or older
- Can read and understand English
- Have a desire to participate in a cooking class study with husband/partner
Exclusion Criteria for Partners:
• Are on a strict diet, such as gluten-free diet
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:防止
- 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)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Dietary intervention
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Session 1:The Breakfast Club: ways to increase the healthiness of breakfast and all meals. Session 2: Calcium and Vitamin D -Keys to Bone Health Session 3: Fruits and Veggies -Your New Best Friends Session 4: Let's Talk About Fat Session 5: Shopping Therapy Session 6: Celebrity Chefs Share Their Secrets
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 |
時間枠 |
---|---|
Feasibility of the intervention as measured through study accrual
時間枠:up to six weeks per session
|
up to six weeks per session
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Feasibility of the intervention as measured through participant adherence
時間枠:up to six weeks per session
|
up to six weeks per session
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Feasibility of the intervention as measured through participant retention
時間枠:up to 6 weeks per session
|
up to 6 weeks per session
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Feasibility of the intervention as measured through participant satisfaction interviews
時間枠:3-months post intervention
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3-months post intervention
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Change in anthropometric measures (height, weight, hip and waist)
時間枠:Baseline and 6 weeks
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Baseline and 6 weeks
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Change in relationship quality measured by the 15-item Mutuality Scale
時間枠:Baseline and six weeks
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Baseline and six weeks
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Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
時間枠:Baseline and 6 weeks
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Baseline and 6 weeks
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Change in quality of life using the 12-Item Short Form Health Survey
時間枠:Baseline and six weeks
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Baseline and six weeks
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Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)
時間枠:Baseline and 6 weeks
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Baseline and 6 weeks
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Change in relationship using the Relationship Assessment Scale
時間枠:Baseline and 6 weeks
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Baseline and 6 weeks
|
協力者と研究者
捜査官
- 主任研究者:Carolyn Gotay, PhD、University of British Columbia
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
キーワード
その他の研究ID番号
- 702413
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?
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。
前立腺がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Dietary interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)積極的、募集していない
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺