- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03191968
Prostate Cancer Survivors and Exercise and Behavioral Counseling (BOOST)
A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Illinois
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Urbana, Illinois, Stati Uniti, 61801
- University of Illinois at Urbana-Champaign
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
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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
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Objectively assessed physical activity
Lasso di tempo: Change in from baseline at 12 weeks
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Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+)
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Change in from baseline at 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Self-reported physical activity
Lasso di tempo: Change in from baseline at 12 weeks
|
Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire
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Change in from baseline at 12 weeks
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Physical Function
Lasso di tempo: Change in from baseline at 12 weeks
|
Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test.
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Change in from baseline at 12 weeks
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General quality of life
Lasso di tempo: Change in from baseline at 12 weeks
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Self-reported quality of life measured via the Functional Assessment of Cancer Therapy (FACT-G) for general quality of life.
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Change in from baseline at 12 weeks
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Prostate-specific quality of life
Lasso di tempo: Change in from baseline at 12 weeks
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Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life.
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Change in from baseline at 12 weeks
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Cancer-related fatigue
Lasso di tempo: Change in from baseline at 12 weeks
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Self-reported fatigue will be assessed using the FACT-Fatigue
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Change in from baseline at 12 weeks
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General well-being
Lasso di tempo: Change in from baseline at 12 weeks
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Self-reported Short-Form 36 will be used for assessing general well-being.
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Change in from baseline at 12 weeks
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Body composition
Lasso di tempo: Change in from baseline at 12 weeks
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Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference.
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Change in from baseline at 12 weeks
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Cardiorespiratory fitness
Lasso di tempo: Change in from baseline at 12 weeks
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Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test.
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Change in from baseline at 12 weeks
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Cognitive function
Lasso di tempo: 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.
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Change in from baseline at 12 weeks
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Sexual Health
Lasso di tempo: 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.
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Change in from baseline at 12 weeks
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Relationship quality
Lasso di tempo: Change in from baseline at 12 weeks
|
The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality.
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Change in from baseline at 12 weeks
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Masculine self-esteem
Lasso di tempo: Change in from baseline at 12 weeks
|
Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I).
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Change in from baseline at 12 weeks
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Motivational outcomes
Lasso di tempo: 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
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Change in from baseline at 12 weeks
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Self-reported sedentary behavior
Lasso di tempo: Change in from baseline at 12 weeks
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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.
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Change in from baseline at 12 weeks
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Objectively assessed sedentary behavior
Lasso di tempo: Change in from baseline at 12 weeks
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Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs)
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Change in from baseline at 12 weeks
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Linda Trinh, PhD, University of Illinois at Urbana-Champaign
- Direttore dello studio: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
- Direttore dello studio: Art F Kramer, PhD, University of Illinois at Urbana-Champaign and Northeastern University
- Direttore dello studio: Kendrith M Rowland, MD, Carle Cancer Center
Pubblicazioni e link utili
Pubblicazioni generali
- Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
- Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2.
- Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.
- Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
- Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. Erratum In: CA Cancer J Clin. 2013 May;63(3):215.
- Bonn SE, Sjolander A, Lagerros YT, Wiklund F, Stattin P, Holmberg E, Gronberg H, Balter K. Physical activity and survival among men diagnosed with prostate cancer. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):57-64. doi: 10.1158/1055-9965.EPI-14-0707. Epub 2014 Dec 19.
- Courneya KS, Friedenreich CM, Reid RD, Gelmon K, Mackey JR, Ladha AB, Proulx C, Vallance JK, Segal RJ. Predictors of follow-up exercise behavior 6 months after a randomized trial of exercise training during breast cancer chemotherapy. Breast Cancer Res Treat. 2009 Mar;114(1):179-87. doi: 10.1007/s10549-008-9987-3. Epub 2008 Apr 4.
- Antonelli J, Freedland SJ, Jones LW. Exercise therapy across the prostate cancer continuum. Prostate Cancer Prostatic Dis. 2009;12(2):110-5. doi: 10.1038/pcan.2009.4. Epub 2009 Mar 10.
- Baumann FT, Zopf EM, Bloch W. Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. Support Care Cancer. 2012 Feb;20(2):221-33. doi: 10.1007/s00520-011-1271-0. Epub 2011 Oct 12.
- Courneya KS, Segal RJ, Gelmon K, Reid RD, Mackey JR, Friedenreich CM, Proulx C, Lane K, Ladha AB, Vallance JK, McKenzie DC. Predictors of supervised exercise adherence during breast cancer chemotherapy. Med Sci Sports Exerc. 2008 Jun;40(6):1180-7. doi: 10.1249/MSS.0b013e318168da45.
- Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Cancer Nurs. 2014 Sep-Oct;37(5):E8-22. doi: 10.1097/NCC.0b013e3182a40fb6.
- Treanor CJ, Li J, Donnelly M. Cognitive impairment among prostate cancer patients: An overview of reviews. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12642. Epub 2017 Feb 7.
- Trinh L, Kramer AF, Rowland K, Strom DA, Wong JN, McAuley E. A pilot feasibility randomized controlled trial adding behavioral counseling to supervised physical activity in prostate cancer survivors: behavior change in prostate cancer survivors trial (BOOST). J Behav Med. 2021 Apr;44(2):172-186. doi: 10.1007/s10865-020-00185-8. Epub 2020 Sep 26.
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Altri numeri di identificazione dello studio
- IRB (University Hospital in Lund)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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