Prostate Cancer Survivors and Exercise and Behavioral Counseling (BOOST)

University of Illinois at Urbana-Champaign

Status and phase: Completed; Phase 2

Conditions: Physical Activity; Cognitive Impairment; Quality of Life; Cancer of the Prostate

Treatments: Behavioral: Supervised Physical Activity Plus Behavioral Counseling; Behavioral: Supervised Physical Activity Plus Exercise Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03191968

IRB (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Supervised PA Plus Behavioral Counseling

Experimental group

Description:

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

Treatment:

Behavioral: Supervised Physical Activity Plus Behavioral Counseling

Supervised PA Plus Exercise Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supervised Physical Activity Plus Exercise Counseling