Overview

This trial is active, not recruiting.

Conditions sedentary, skin cancer
Treatments tailored internet communication with relational agent, tailored internet communications
Sponsor University of Rhode Island
Collaborator Northeastern University
Start date April 2009
End date September 2011
Trial size 1360 participants
Trial identifier NCT01458002, CA119195

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(No Intervention)
Assessment only
(Other)
TTM expert system only
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.
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)
TTM expert system plus relational agent
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.

Primary Outcomes

Measure
Exercise
time frame: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
Sun Exposure
time frame: Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months

Secondary Outcomes

Measure
Exercise
time frame: 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
time frame: 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.

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Principal investigator Wayne F Velicer, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by University of Rhode Island.