Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

15. februar 2021 oppdatert av: University of Kansas Medical Center
The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

  1. Staying Strong & Healthy Intervention + Usual Care
  2. Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

Studietype

Intervensjonell

Registrering (Faktiske)

38

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • University of California, Los Angeles
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Diagnosed with prostate cancer
  • Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
  • Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
  • Able to speak and read in English or Spanish
  • Reachable consistently by telephone
  • Able to travel to KUMC

Exclusion Criteria:

  • Not diagnosed with prostate cancer
  • Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
  • Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
  • Not able to speak and read in English or Spanish
  • Not reachable consistently by telephone
  • Not able to travel to the study site for data collection

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Staying Strong & Healthy Intervention (SS&H)
Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.
Atferdsmessig: Exercise Program
Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
Atferdsmessig: Diet and Nutrition Coaching
Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
Annen: Usual Care with Attention
Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.
Aktiv komparator: Usual Care with Attention (UCA)
Participants will receive the usual care they would normally receive if not taking part in this study.
Annen: Usual Care with Attention
Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in LDL
Tidsramme: Change from Baseline to Month 12
Change from Baseline to Month 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Body Mass Index (BMI)
Tidsramme: Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Lipid Profile
Tidsramme: Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Lipid Profile
Tidsramme: Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Waist/Hip Circumference
Tidsramme: Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Waist/Hip Circumference
Tidsramme: Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Glucose
Tidsramme: Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Glucose
Tidsramme: Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Health Related Quality
Tidsramme: Change from Baseline to Month 6
Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
Change from Baseline to Month 6
Change in Health Related Quality
Tidsramme: Change from Baseline to Month 12
Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
Change from Baseline to Month 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Kansas Medical Center

Samarbeidspartnere

National Institute of Nursing Research (NINR)

Etterforskere

  • Hovedetterforsker: Sally Maliski, PhD, RN, FAAN, University of Kansas Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. mars 2017

Primær fullføring (Faktiske)

1. juli 2020

Studiet fullført (Faktiske)

31. juli 2020

Datoer for studieregistrering

Først innsendt

17. november 2016

Først innsendt som oppfylte QC-kriteriene

17. november 2016

Først lagt ut (Anslag)

21. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00004205
  • R01NR014518 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Exercise Program

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in South Korea

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere