BOOST: Prostate Cancer Survivors and Exercise and Behavioral Counseling

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Completed

CT.gov ID

NCT03191968

Collaborator

(none)

Enrollment

Location

Arms

10.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity Cancer of the Prostate Cognitive Impairment Quality of Life	Behavioral: Supervised Physical Activity Plus Behavioral Counseling Behavioral: Supervised Physical Activity Plus Exercise Counseling	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 6, 2017

Actual Primary Completion Date :

May 30, 2018

Actual Study Completion Date :

May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: 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
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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

Behavioral: 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

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Self-reported physical activity [Change in from baseline at 12 weeks]
Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire
Physical Function [Change in from baseline at 12 weeks]
Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test.
General quality of life [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.
Prostate-specific quality of life [Change in from baseline at 12 weeks]
Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life.
Cancer-related fatigue [Change in from baseline at 12 weeks]
Self-reported fatigue will be assessed using the FACT-Fatigue
General well-being [Change in from baseline at 12 weeks]
Self-reported Short-Form 36 will be used for assessing general well-being.
Body composition [Change in from baseline at 12 weeks]
Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference.
Cardiorespiratory fitness [Change in from baseline at 12 weeks]
Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test.
Cognitive function [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.
Sexual Health [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.
Relationship quality [Change in from baseline at 12 weeks]
The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality.
Masculine self-esteem [Change in from baseline at 12 weeks]
Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I).
Motivational outcomes [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
Self-reported sedentary behavior [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.
Objectively assessed sedentary behavior [Change in from baseline at 12 weeks]
Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

Sponsors and Collaborators

University of Illinois at Urbana-Champaign

Investigators

Principal Investigator: Linda Trinh, PhD, University of Illinois at Urbana-Champaign
Study Director: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Study Director: Art F Kramer, PhD, University of Illinois at Urbana-Champaign and Northeastern University
Study Director: Kendrith M Rowland, MD, Carle Cancer Center