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Clinical Trial 19844

Cancer Type: Gastrointestinal Tumor
Study Type: Screening
NCT#:

Phase: N/A
Principal Investigator: Christy, Shannon

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Overview

Study Title

A Pre-Pilot of a Survivor-Personalized Colorectal Cancer Screening Education Intervention for Adult First-Degree Relatives

Summary

The purpose of this study is to get feedback from both colorectal cancer survivors and first-degree relatives such as parents, siblings, and children of colorectal cancer survivors on the best ways to personalize, deliver, and promote colorectal cancer screening through educational materials for first-degree relatives that will be personalized by their colorectal cancer survivor relative, develop educational materials based upon that feedback, and then see whether colorectal cancer survivors and first-degree relatives receive feedback on the process and how well the process works

Objective

Aim 1 (Phase I/Formative Phase): Develop a personalized educational intervention acceptable to both CRC survivors and FDRs aimed at promoting CRC screening among FDRs not currently adherent to screening guidelines. This will be accomplished via a sequential series of 3 focus groups (one with CRC survivors only, one with FDRs only, and the last with both CRC survivors and FDRs) with approximately 10 participants each for a total of 30 participants (i.e., 15 CRC survivors and 15 FDRs) and a process of iterative refinement of the intervention materials and processes. This phase will provide important direction for the intervention in terms of the personalized message creation process, content, and delivery preferences (e.g., number, order, format, timing, delivery method). This phase will also produce a bank of example messages that will illustrate the creation of theory-based messages to survivors enrolled in future trials. Ultimately, this phase will result in an advanced draft of the intervention materials and processes Aim 2 (Phase II/Pre-pilot Phase): Examine the feasibility, acceptability, and proof of concept of a CRC survivor-personalized intervention to increase FDRs CRC knowledge and screening intentions. This will be accomplished through a single-arm (non-randomized) pre-pilot study which includes individual phone interviews with 25 dyads of CRC survivors and FDRs. In this phase, we will examine the feasibility and acceptability of implementing the intervention. Specifically, we will demonstrate that survivors can create personalized messages for their related FDR and that these messages are acceptable to FDRs. This phase is expected to demonstrate proof of concept for a planned National Cancer Institute modular R01 application for an RCT aimed at evaluating whether the survivor-personalized message intervention improves FDRs CRC knowledge, encourages CRC screening discussions, improves screening intentions among FDRs, and promotes CRC screening uptake among FDRs compared to non-personalized education

Treatments

Therapies

Medications

Inclusion Criteria

Phase 1 (Colorectal cancer survivors)

  • Age 18 or older
  • Diagnosis of non-metastatic colorectal cancer, diagnosed within past 3 months -5 years
  • Willing and able to participate in in-person focus group or individual interview, or in a remote focus group or individual interview
  • Able to read, write, speak and understand English
  • Able to provide verbal informed consent
  • Willing to be audio recorded during the discussion section of the focus group or individual interview
  • Regular access to a working telephone
  • Either a current mailing address and/or access to the internet and a working email address. Phase 2 (first-degree relatives):
  • Age 40 to 75
  • No personal history of colorectal cancer or current colorectal cancer symptoms
  • Able to read, write, speak, and understand English
  • Able to provide verbal informed consent
  • Willing and able to participate in an in- person focus group or in-person individual interview or in a remote focus group or remote individual interview
  • Willing to be voice recorded (audiorecorded) during the discussion section of the focus group or individual interview
  • Regular access to a working telephone

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.