RECRUITING

Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)

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 study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

Official Title

Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials

Quick Facts

Study Start:2025-02-20
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06822049

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:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Common to all 3 RCTs:
  1. * Specific to RCT 1:
  2. 1. use of tobacco/nicotine products other than cigarettes more than once per week
  3. 2. prior allergy/intolerance to NRT patch or lozenge
  4. 3. FDA-specified contraindications for use of NRT
  5. 4. use of tobacco/nicotine products other than cigarettes more than once per week
  6. 5. prior allergy/intolerance to NRT patch or lozenge
  7. 6. FDA-specified contraindications for use of NRT
  8. 7. . pregnant, breastfeeding, or planning to become pregnant
  9. 8. self-reported recent (past 1 month) cardiovascular event: MI, stroke
  10. 9. current use of any smoking cessation medication or antipsychotic medication
  11. 10. daily/near-daily binge drinking or alcohol dependence (NIDA Quick Screen; AUDIT\>15)
  12. 11. high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST\>=27)
  13. 12. past-year suicide attempt
  14. 13. active and unstable major medical/psychiatric conditions

Contacts and Locations

Study Contact

Larry W Hawk, PhD
CONTACT
716-645-0192
lhawk@buffalo.edu

Study Locations (Sites)

University at Buffalo
Buffalo, New York, 14260
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

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 Date2025-02-20
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2025-02-20
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • Remote vs. In-Person methods

Additional Relevant MeSH Terms

  • Remote vs. In-Person
  • Remote Visits
  • In-person Visits