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Prostate Cancer Survivors and Exercise and Behavioral Counseling (BOOST)

2019년 12월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

27

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Illinois
      • Urbana, Illinois, 미국, 61801
        • University of Illinois at Urbana-Champaign

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

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

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
행동: 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
활성 비교기: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objectively assessed physical activity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Self-reported physical activity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Illinois at Urbana-Champaign

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (실제)

2017년 7월 6일

기본 완료 (실제)

2018년 5월 30일

연구 완료 (실제)

2018년 5월 30일

연구 등록 날짜

최초 제출

2017년 6월 12일

QC 기준을 충족하는 최초 제출

2017년 6월 14일

처음 게시됨 (실제)

2017년 6월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 12월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 12월 19일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB (기타 식별자: University of Rhode Island)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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정황

희귀 질병

약물 개입

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스폰서 / 협력자

위치

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