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

15. februar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • University of California, Los Angeles
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Kansas Medical Center

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

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

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 (Faktiske)

7. marts 2017

Primær færdiggørelse (Faktiske)

1. juli 2020

Studieafslutning (Faktiske)

31. juli 2020

Datoer for studieregistrering

Først indsendt

17. november 2016

Først indsendt, der opfyldte QC-kriterier

17. november 2016

Først opslået (Skøn)

21. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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