NCT03279198

Brief Summary

This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:

  1. 1.usual care;
  2. 2.a TIWeb (tailored intervention Website)
  3. 3.a CSC (cancer screening call) and
  4. 4.TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

5.2 years

First QC Date

August 22, 2017

Last Update Submit

September 8, 2017

Conditions

Breast Cancer FemaleColorectal Cancer

Keywords

breast cancer screeningcolorectal cancer screeningcervical cancer screeningcancer screening beliefscost-effectivenessdemographicstailored intervention

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome -differences in CRC screening adherence, when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.

    any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy

    6 months from the baseline measure

  • Primary Outcome:differences in stage of adoption (precontemplation, contemplation, action) when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.

    Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action

    6 months from the baseline measure

Secondary Outcomes (1)

  • Secondary outcome:Intervention Costs

    6 months from the baseline measure

Study Arms (4)

Usual Care (UC)

PLACEBO COMPARATOR

The usual care group received usual care that varies dependent upon the practice setting.

Behavioral: UC

TIWeb

ACTIVE COMPARATOR

TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

Behavioral: TIWeb

Cancer Screening Call (CSC)

ACTIVE COMPARATOR

CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

Behavioral: CSC

TIWeb+CSC

ACTIVE COMPARATOR

TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

Behavioral: TIWeb+CSC

Interventions

TIWebBEHAVIORAL

Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

Also known as: Tailored Web Intervention
TIWeb
CSCBEHAVIORAL

Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

Also known as: Cancer Screening Call
Cancer Screening Call (CSC)
UCBEHAVIORAL

Intervention: The usual care group received usual care that varies dependent upon the practice setting.

Also known as: Usual Care
Usual Care (UC)
TIWeb+CSCBEHAVIORAL

Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

Also known as: Tailored Web Intervention + Cancer Screening Call
TIWeb+CSC

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages from 50 - 75.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a patient of any of the participating physicians
  • not having had a fecal occult blood test (fobt) in the last 12 months
  • not having had a fecal immunochemical test (fit) in the past 15 months
  • not having had sigmoidoscopy more than 5 years ago
  • not having had a colonoscopy more than 10 years ago
  • have high-speed internet access

You may not qualify if:

  • a personal history of colorectal cancer
  • a personal history of breast cancer
  • a personal history of colorectal polyps
  • a personal history of inflammatory bowel disease
  • having any medical conditions that would prohibit a mammogram or CRC screening
  • have already had CRC screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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  • Huang D, Lairson DR, Chung TH, Monahan PO, Rawl SM, Champion VL. Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women. Cancer Prev Res (Phila). 2021 Sep;14(9):905-916. doi: 10.1158/1940-6207.CAPR-21-0009. Epub 2021 Jul 9.

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  • Champion VL, Christy SM, Rakowski W, Lairson DR, Monahan PO, Gathirua-Mwangi WG, Stump TE, Biederman EB, Kettler CD, Rawl SM. An RCT to Increase Breast and Colorectal Cancer Screening. Am J Prev Med. 2020 Aug;59(2):e69-e78. doi: 10.1016/j.amepre.2020.03.008.

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  • Lairson DR, Chung TH, Huang D, Stump TE, Monahan PO, Christy SM, Rawl SM, Champion VL. Economic Evaluation of Tailored Web versus Tailored Telephone-Based Interventions to Increase Colorectal Cancer Screening among Women. Cancer Prev Res (Phila). 2020 Mar;13(3):309-316. doi: 10.1158/1940-6207.CAPR-19-0376. Epub 2020 Jan 22.

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Victoria Champion, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control

Study Record Dates

First Submitted

August 22, 2017

First Posted

September 12, 2017

Study Start

July 22, 2010

Primary Completion

September 15, 2015

Study Completion

May 31, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Box Health) that is password protected.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
January 1st, 2017 - March 31st, 2020.
Access Criteria
Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Victoria Champion can submit a request.