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Prostate Cancer Survivors and Exercise and Behavioral Counseling (BOOST)

19. desember 2019 oppdatert av: University of Illinois at Urbana-Champaign

A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors

This study will evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS). Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Physical activity (PA) has a positive impact on clinical outcomes such as improvement in overall QoL, cancer-specific mortality, reducing treatment-related toxicities, and reducing fatigue across many cancer survivor groups including PCS. Despite these benefits of regular PA, the majority of PCS are still not meeting public health PA guidelines.

Short-term supervised PA programs have been shown to improve health-related fitness and patient-reported outcomes in PCS, but PA declines significantly after the supervised intervention has been completed. Research examining the effect of short- term supervised exercise programs on motivational outcomes and longer term PA among cancer survivors is limited, especially theoretical approaches to identify key motivational outcomes for behavior change.

This study will pilot a two-armed, single blind, RCT comparing SPA+EC to SPA+BC. The proposed RCT in PCS is noteworthy given that it differs from standard approaches to supervised PA with the addition of a behavioral counseling component. This rigorous comparison condition will provide further evidence that theoretically-informed interventions are needed to adopt long-term PA maintenance.

The program's supervised exercise length will be 6 weeks, followed by a tapered contact throughout the a 6-week home-based component through 'booster' behavioral counseling delivered via telephone. In terms of study measures, objective measures of PA will be used (i.e.,accelerometry, inclinometers), and cardiorespiratory fitness will be evaluated using maximal graded exercise testing via treadmill. Additional secondary outcomes include cognitive function, quality of life, physical function, body composition, motivational outcomes, sexual functioning, masculinity, sedentary behavior, and cardiorespiratory fitness.

Studietype

Intervensjonell

Registrering (Faktiske)

27

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Illinois
      • Urbana, Illinois, Forente stater, 61801
        • University of Illinois at Urbana-Champaign

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • ≥18 years and older
  • Histologically confirmed prostate cancer (Stage I-IIIa) but now cured or in remission
  • Ability and willingness to effectively communicate in English
  • Not meeting physical activity guidelines of ≥150 minutes of vigorous physical activity

Exclusion Criteria:

  • Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
  • Significant congestive heart failure (New York Heart Association class III or greater)
  • Uncontrolled pain
  • Neurological or musculoskeletal co-morbidity inhibiting exercise
  • Diagnosed psychotic, addictive or major cognitive disorders
  • Absent for more than 3 consecutive days during the 12-week intervention
  • High risk individuals (i.e., men who have symptomatic and known cardiovascular, pulmonary and/or metabolic disease) as determined by the risk stratification questionnaire

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Supervised PA Plus Behavioral Counseling
25 prostate cancer survivors will receive supervised physical activity and behavioral counseling (SPA+BC) based on the M-PAC. In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation
Atferdsmessig: Supervised Physical Activity Plus Behavioral Counseling
In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation
Aktiv komparator: Supervised PA Plus Exercise Counseling
25 prostate cancer survivors will supervised physical activity and exercise counseling (SPA+EC).In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline.
Atferdsmessig: Supervised Physical Activity Plus Exercise Counseling
In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objectively assessed physical activity
Tidsramme: Change in from baseline at 12 weeks
Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+)
Change in from baseline at 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-reported physical activity
Tidsramme: Change in from baseline at 12 weeks
Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire
Change in from baseline at 12 weeks
Physical Function
Tidsramme: Change in from baseline at 12 weeks
Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test.
Change in from baseline at 12 weeks
General quality of life
Tidsramme: Change in from baseline at 12 weeks
Self-reported quality of life measured via the Functional Assessment of Cancer Therapy (FACT-G) for general quality of life.
Change in from baseline at 12 weeks
Prostate-specific quality of life
Tidsramme: Change in from baseline at 12 weeks
Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life.
Change in from baseline at 12 weeks
Cancer-related fatigue
Tidsramme: Change in from baseline at 12 weeks
Self-reported fatigue will be assessed using the FACT-Fatigue
Change in from baseline at 12 weeks
General well-being
Tidsramme: Change in from baseline at 12 weeks
Self-reported Short-Form 36 will be used for assessing general well-being.
Change in from baseline at 12 weeks
Body composition
Tidsramme: Change in from baseline at 12 weeks
Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference.
Change in from baseline at 12 weeks
Cardiorespiratory fitness
Tidsramme: Change in from baseline at 12 weeks
Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test.
Change in from baseline at 12 weeks
Cognitive function
Tidsramme: Change in from baseline at 12 weeks
The primary set of neuropsychological assessments will be assessed using the validated NIH Toolbox Cognition Battery. This battery consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Change in from baseline at 12 weeks
Sexual Health
Tidsramme: Change in from baseline at 12 weeks
The International Index of Erectile Function (IIEF) will be used to assess sexual health including erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction.
Change in from baseline at 12 weeks
Relationship quality
Tidsramme: Change in from baseline at 12 weeks
The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality.
Change in from baseline at 12 weeks
Masculine self-esteem
Tidsramme: Change in from baseline at 12 weeks
Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I).
Change in from baseline at 12 weeks
Motivational outcomes
Tidsramme: Change in from baseline at 12 weeks
multi-process action control (M-PAC) framework assessing attitudes, subjective norms, perceived behavioral control, planning, habit, and identity
Change in from baseline at 12 weeks
Self-reported sedentary behavior
Tidsramme: Change in from baseline at 12 weeks
sitting time as measured by via self-report using the Measuring Older Adults' Sedentary Time (MOST) questionnaire which assesses sitting while watching TV, using the computer, hobbies, socializing, transportation, doing hobbies, and other activities.
Change in from baseline at 12 weeks
Objectively assessed sedentary behavior
Tidsramme: Change in from baseline at 12 weeks
Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs)
Change in from baseline at 12 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

University of Illinois at Urbana-Champaign

Etterforskere

  • Hovedetterforsker: Linda Trinh, PhD, University of Illinois at Urbana-Champaign
  • Studieleder: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
  • Studieleder: Art F Kramer, PhD, University of Illinois at Urbana-Champaign and Northeastern University
  • Studieleder: Kendrith M Rowland, MD, Carle Cancer Center

Publikasjoner og nyttige lenker

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Generelle publikasjoner

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)

6. juli 2017

Primær fullføring (Faktiske)

30. mai 2018

Studiet fullført (Faktiske)

30. mai 2018

Datoer for studieregistrering

Først innsendt

12. juni 2017

Først innsendt som oppfylte QC-kriteriene

14. juni 2017

Først lagt ut (Faktiske)

19. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2019

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB (Annen identifikator: University of Rhode Island)

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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