Clinical trial NCT03191968: Prostate Cancer Survivors and Exercise and Behavioral Counseling
Official title: A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Physical Activity
Cancer of the Prostate
Cognitive Impairment
Quality of Life
Keywords: Behavior change
Prostate cancer
Behavioral counseling
Physical Activity
Randomized controlled trial
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objectively assessed physical activity
timeFrame: Change in from baseline at 12 weeks
Secondary outcomes:
measure: Self-reported physical activity
timeFrame: Change in from baseline at 12 weeks
measure: Physical Function
timeFrame: Change in from baseline at 12 weeks
measure: General quality of life
timeFrame: Change in from baseline at 12 weeks
measure: Prostate-specific quality of life
timeFrame: Change in from baseline at 12 weeks
measure: Cancer-related fatigue
timeFrame: Change in from baseline at 12 weeks
measure: General well-being
timeFrame: Change in from baseline at 12 weeks
measure: Body composition
timeFrame: Change in from baseline at 12 weeks
measure: Cardiorespiratory fitness
timeFrame: Change in from baseline at 12 weeks
measure: Cognitive function
timeFrame: Change in from baseline at 12 weeks
measure: Sexual Health
timeFrame: Change in from baseline at 12 weeks
measure: Relationship quality
timeFrame: Change in from baseline at 12 weeks
measure: Masculine self-esteem
timeFrame: Change in from baseline at 12 weeks
measure: Motivational outcomes
timeFrame: Change in from baseline at 12 weeks
measure: Self-reported sedentary behavior
timeFrame: Change in from baseline at 12 weeks
measure: Objectively assessed sedentary behavior
timeFrame: Change in from baseline at 12 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Linda Trinh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Edward McAuley, PhD
role: STUDY_DIRECTOR
affiliation: University of Illinois at Urbana-Champaign and Northeastern University
name: Art F Kramer, PhD
role: STUDY_DIRECTOR
affiliation: Carle Cancer Center
name: Kendrith M Rowland, MD
role: STUDY_DIRECTOR
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