Online Tailored Interventions & Relational Agents for Exercise and Sun Protection (Project RAISE)

This study targets two major risk factors for cancer; is designed to treat the behaviors on a population basis, using proactive recruitment strategies; intervenes on multiple behaviors simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the most promising approaches to low cost population based interventions for health-related behavior change, namely the internet; and develops and tests a promising new approach to increasing the utilization and effectiveness of internet-based interventions, relational agents. The primary aims are: (1) To develop and assess the effectiveness of a tailored internet intervention on a national sample; (2) To develop and assess the effectiveness of the internet intervention enhanced by a relational agent; and (3) To determine if the intervention with the relational agent can outperform the regular tailored internet intervention.

Study Overview

• Status: Completed
• Conditions: Skin Cancer; Sedentary
• Intervention / Treatment: Other: Tailored Internet Communication with Relational Agent; Other: Tailored Internet Communications

Detailed Description

The overarching goal of this research project is to revise and enhance a multimedia computer-based multiple risk factor intervention for cancer prevention, using the internet to reach a general population. Two innovative, individualized, easily disseminated, low-cost, and interactive interventions, both for multiple behaviors (sun protection and exercise adoption), will be developed and evaluated in comparison to a control condition. The first intervention involves adapting our effective multimedia expert system interventions to the internet environment. The second intervention builds on the first with the additional inclusion of a Relational Agent, a recently developed computer-based approach to establishing a personal relationship typically missing on internet sites. Both systems will employ the same theoretical model of behavior change, the Transtheoretical Model, as the deep knowledge, and all systems will employ empirically based decision rules. The design is a 3 Group (Control, Internet, Internet plus Relational Agent) x 3 Occasions (0, 12, 24 • Months) with intervention occurring during the first 12 months. A representative national sample of 1639 individuals at risk for both behaviors will be recruited. The primary aims are: (1) To develop and assess the effectiveness of a tailored internet intervention on a national sample; (2) To develop and assess the effectiveness of the internet intervention enhanced by a relational agent; and (3) To determine if the intervention with the relational agent can outperform the regular tailored internet intervention. The secondary aims are: (1) To determine if the two interventions are differentially effective with each behavior and with different subgroups, and (2) To determine if the relational agent intervention is utilized more often for increasing exercise than for sun protection. This study targets two major risk factors for cancer; is designed to treat the behaviors on a population basis, using proactive recruitment strategies; intervenes on multiple behaviors simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the most promising approaches to low cost population based interventions for health-related behavior change, namely the internet; and develops and tests a promising new approach to increasing the utilization and effectiveness of internet-based interventions, relational agents.

• Study Type: Interventional
• Enrollment (Actual): 1364
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Kingston, Rhode Island, United States, 02881
      • University of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speaking
• access to computer
• willing to download materials

Exclusion Criteria:

• heart attack in past 6 months
• kidney failure during dialysis
• currently receiving chemotherapy or radiation for cancer
• had a seizure in the past 6 months
• had a leg or pelvic fracture in the past 6 months
• legally blind
• regularly use a wheelchair
• (women only) currently pregnant or plan to be pregnant in the next 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Assessment only
Other: Tailored Internet Communications; TTM expert system only	Other: Tailored Internet Communication with Relational Agent; The Tailored Internet Intervention will include a "relational agent" component, which is an animated conversational agent that builds a working relationship with subjects over time and uses this alliance to boost intervention effectiveness and retention to the Tailored Internet Communications web site.; Other: Tailored Internet Communications; Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
Experimental: Tailored Internet Communication with Relational Agent; TTM expert system plus relational agent	Other: Tailored Internet Communication with Relational Agent; The Tailored Internet Intervention will include a "relational agent" component, which is an animated conversational agent that builds a working relationship with subjects over time and uses this alliance to boost intervention effectiveness and retention to the Tailored Internet Communications web site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise	Regular Exercise is defined as any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, basketball, etc.) performed to increase physical fitness. Such activity should be performed 5 times or more per week for 30 minutes per session, consistent with CDC guidelines.	Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
Sun Exposure	Consistently protecting themselves from the sun every time they were out in the sun for 15+ minutes is defined as 1) using sunscreens with a sun protection factor (SPF) of 15 or more, wearing protective clothing (for example, a hat with a wide brim, shirts, and pants), and avoiding or limiting exposure to the sun during the mid-day hours (10 am - 4 pm).	Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Exercise	Increase in number of minutes of physical activity per week (150 minutes of moderate intensity or 75 minutes of vigorous intensity) measured by the International Physical Activity Questionnaire (IPAT)
Sun Exposure	Increase in number of sun protection behaviors as measured by the Sun Protection Behavior Scale (SPBS), which consists of three scales: sunscreen use, sun avoidance and protective clothing, and hat use.

Collaborators and Investigators

• Sponsor: University of Rhode Island
• Collaborators: Northeastern University; Pro-Change Behavior Systems
• Investigators: Principal Investigator: Wayne F Velicer, PhD, Univeristy of Rhode Island

Publications and helpful links

General Publications

• Redding CA, Prochaska JO, Paiva A, Rossi JS, Velicer W, Blissmer BJ, Greene GW, Robbins ML, Sun X. Baseline stage, severity, and effort effects differentiate stable smokers from maintainers and relapsers. Subst Use Misuse. 2011;46(13):1664-74. doi: 10.3109/10826084.2011.565853. Epub 2011 Mar 30.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: CA119195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO