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Counterfactual Strategy for Financial Toxicity

N/A
Waitlist Available
Led By Rachel E Smallman, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly (14 weeks); collected every day via the fitbit device for the 14-week duration of the study. will assess weekly change over the course of the 14 week period.
Awards & highlights

Study Summary

Physical activity (PA) has been suggested to lower one's risk of developing cancer, type 2 diabetes, and cardiovascular disease. While there are benefits from engaging in PA, many people do not engage in enough daily PA, thus increasing the chance of developing non-communicable diseases (NCD). Some NCDs, such as type 2 diabetes, have been shown to occur at higher rates within under-resourced populations, such as low socioeconomic status (SES) communities. Among low-SES communities, external barriers, such as cost and the surrounding physical environment, have been shown to impact engagement in PA. A multi-level PA intervention could be beneficial to help lower NCD health outcomes within at-risk groups, as well as serve as a means to further understand the barriers impeding a healthy lifestyle. At the individual level, past behavior is suggested to be a significant predictor of future behavior. When faced with a NCD diagnosis, one might think about the past and how things could have turned out differently (i.e., counterfactual thinking). For instance, what if a different action had been taken (e.g., "If only I had taken the stairs more at work")? Counterfactuals can also serve as a way of identifying causal links (e.g., "If only there were more green spaces in my area..."). Counterfactuals (CF) on behaviors that can be acted on can facilitate future behavior change by increasing intentions, motivation, and self-efficacy. In this way, CFs might help with 1) breaking a habitual sedentary cycle and 2) identify causal pathways of barriers impacting PA engagement. While preliminary data in the investigators lab suggests that CF strategies are relevant for heightening contemplation to change behaviors and intentions to change behaviors its impact on motivation and self-efficacy remains unknown. Additionally, these preliminary studies were conducted using small, undergraduate student sample, thus generalizability to low-SES individuals living in the surrounding community is unknown. For the proposed study, participants will use CFs to target barriers in different domains and levels of influence impeding PA. This identification effort will be used to work towards increasing PA behavior (collected by wearable fitness trackers). CFs will also be used to work towards increasing psychological domains relevant to behavior change over the span of 14 weeks.

Eligible Conditions
  • Financial Toxicity
  • Financial Stress
  • Socioeconomic Status
  • Social Status

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly (14 weeks); collected every day via the fitbit device for the 14-week duration of the study. will assess weekly change over the course of the 14 week period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly (14 weeks); collected every day via the fitbit device for the 14-week duration of the study. will assess weekly change over the course of the 14 week period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fitbit Active Zone Minutes
Secondary outcome measures
Contemplation Ladder
Physical Activity Intentions
Physical Activity Motivation
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Counterfactual Strategy InterventionExperimental Treatment1 Intervention
After participants finish describing past events where they were unable to participate or engage in physical activity and have identified barriers which impacted their events they just described, participants will be randomly assigned to conditions. Participants in the counterfactual strategy condition will engage in counterfactual strategies on barriers they believe they could have reasonably acted on to increase physical activity in their described event(s) that would have led to a better outcome. After identifying the counterfactual strategies, participants will then select three counterfactual strategies they just identified that they could use at some point in the upcoming week, any obstacles to using that counterfactual strategy, ways to overcome those obstacles, their intention to use the counterfactual strategy over the next week, and how likely they think the counterfactual strategy would have happened and led to the better outcome.
Group II: ControlActive Control1 Intervention
Participants will be asked to describe past events where they were unable to participate or engage in physical activity. All participants will walk through the NIMHD framework with a researcher and be guided to identify barriers at various domains and levels of influence, which impacted their events they just described. After barrier identification, participants will be asked to select three barriers to talk aloud and list out additional details about the barriers identified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Counterfactual Strategy
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
140 Previous Clinical Trials
24,066 Total Patients Enrolled
U.S. National Science FoundationFED
34 Previous Clinical Trials
8,834 Total Patients Enrolled
Rachel E Smallman, PhDPrincipal InvestigatorTexas A&M University

Frequently Asked Questions

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Recent research and studies
~13 spots leftby Apr 2025