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Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners

2016년 11월 3일 업데이트: Carolyn Gotay, University of British Columbia

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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

44

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6T1Z3
        • University of British Columbia

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Dietary intervention

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

다른 이름들:
  • Cooking classes

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Feasibility of the intervention as measured through study accrual
기간: up to six weeks per session
up to six weeks per session
Feasibility of the intervention as measured through participant adherence
기간: up to six weeks per session
up to six weeks per session
Feasibility of the intervention as measured through participant retention
기간: up to 6 weeks per session
up to 6 weeks per session
Feasibility of the intervention as measured through participant satisfaction interviews
기간: 3-months post intervention
3-months post intervention

2차 결과 측정

결과 측정
기간
Change in anthropometric measures (height, weight, hip and waist)
기간: Baseline and 6 weeks
Baseline and 6 weeks
Change in relationship quality measured by the 15-item Mutuality Scale
기간: Baseline and six weeks
Baseline and six weeks
Change in dietary outcome using a modified version of the National Institutes of Health Quick Food Scan
기간: Baseline and 6 weeks
Baseline and 6 weeks
Change in quality of life using the 12-Item Short Form Health Survey
기간: Baseline and six weeks
Baseline and six weeks
Change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q)
기간: Baseline and 6 weeks
Baseline and 6 weeks
Change in relationship using the Relationship Assessment Scale
기간: Baseline and 6 weeks
Baseline and 6 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Carolyn Gotay, PhD, University of British Columbia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 2월 1일

기본 완료 (실제)

2016년 9월 1일

연구 완료 (실제)

2016년 9월 1일

연구 등록 날짜

최초 제출

2016년 11월 1일

QC 기준을 충족하는 최초 제출

2016년 11월 1일

처음 게시됨 (추정)

2016년 11월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 3일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

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아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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