ACTIVE_NOT_RECRUITING

Construal Level as a Novel Pathway for Affect Regulation and Cancer Control

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the proposed research is to conduct a longitudinal experiment on the neurocognitive pathways and individual differences in high-level construal for affect regulation and smoking cessation. The population is adult smokers aged 25-55 who have tried and failed to quit and who are experiencing poverty. The primary endpoints are (a) the similarity in neural representation of high-level construal to one of two candidate pathways, (b) the presence of meaningful individual differences in the neural representation of high-level construal, and (c) as a secondary endpoint, the effect size of the high-level construal condition on smoking as measured by cigarettes per day. Each of these endpoints corresponds to a specific null hypothesis. The null hypothesis for the first endpoint is that high-level construal is not significantly different in its neural representation from down-regulation of craving, which would suggest that high-level construal does not operate through distinct mechanisms from traditional treatments. The null hypothesis for the second endpoint is that the between-subjects variability in the neural representation of construal level does not significantly relate to relevant individual differences measures (e.g., traits, task behavior), which would suggest that individual differences are not meaningfully related to outcomes. Finally, the null hypothesis for the secondary endpoint is that the magnitude of the effect of high-level construal on smoking as measured by reductions in average cigarettes per day is not significantly greater than in the other conditions, which would suggest that the efficacy of the high-level construal condition is not significantly greater than a standard text-messaging intervention. The primary endpoints will be assessed at baseline and change from pre-to-post training (8 weeks).

Official Title

High-level Construal as a Novel Pathway for Affect Regulation and Cancer Control

Quick Facts

Study Start:2021-10-11
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04620915

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Low-SES
  2. 2. Persistent smokers: cigarette smokers (at least 10 cigarettes/day for at least 1 year)
  3. 3. Want to quit but have tried and failed at least once
  4. 4. Income-to-needs ratio (INR) is less than 2.0, meaning that their household income adjusted for household size is below 200% of the federal poverty line
  5. 5. Ages 25-55
  1. 1. Metal implants (e.g., braces, permanent retainers, pins)
  2. 2. Metal fragments, pacemakers or other electronic medical implants
  3. 3. Claustrophobia
  4. 4. Weight ˃ 550 lbs.
  5. 5. Women who are pregnant or believe they might be pregnant

Contacts and Locations

Principal Investigator

Elliot T Berkman, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Oregon

Study Locations (Sites)

University of Oregon, Lewis Integrative Sciences Building
Eugene, Oregon, 97403
United States
University of Oregon, Social and Affective Neuroscience Laboratory
Eugene, Oregon, 97403
United States

Collaborators and Investigators

Sponsor: University of Oregon

  • Elliot T Berkman, Ph.D., PRINCIPAL_INVESTIGATOR, University of Oregon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-10-11
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Smoking
  • Construal level
  • Cigarettes
  • Quitting

Additional Relevant MeSH Terms

  • Smoking Cessation
  • Smoking Reduction
  • Cancer