Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

3. november 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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

Andre navne:
  • Cooking classes

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Change in anthropometric measures (height, weight, hip and waist)
Tidsramme: Baseline and 6 weeks
Baseline and 6 weeks
Change in relationship quality measured by the 15-item Mutuality Scale
Tidsramme: 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
Tidsramme: Baseline and 6 weeks
Baseline and 6 weeks
Change in quality of life using the 12-Item Short Form Health Survey
Tidsramme: 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)
Tidsramme: Baseline and 6 weeks
Baseline and 6 weeks
Change in relationship using the Relationship Assessment Scale
Tidsramme: Baseline and 6 weeks
Baseline and 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Carolyn Gotay, PhD, University of British Columbia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

1. november 2016

Først indsendt, der opfyldte QC-kriterier

1. november 2016

Først opslået (Skøn)

3. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Dietary intervention

3
Abonner