NCT04409782

Brief Summary

This study investigates different ways to educate rural residents living in New Hampshire and Vermont about cancer research studies and clinical trials to increase knowledge of, increase positive attitudes toward, and encourage enrollment in cancer research studies and clinical trials. The information learned from this study will contribute to a nation-wide initiative to educate the public about clinical trials, including a nation-wide evaluation of that initiative. The results of this study may also help researchers understand how education about clinical trials/research affects knowledge of and attitudes toward cancer research and clinical trials, as well as behavioral intentions and actual behaviors related to enrolling in cancer research studies and clinical trials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 15, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 31, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

May 15, 2020

Last Update Submit

January 15, 2024

Conditions

Keywords

EducationClinical TrialResearch

Outcome Measures

Primary Outcomes (3)

  • Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention

    A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 19 true/false questions and 6 multiple choice questions).

    Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention

  • Percent change in attitudes and behavioral intentions toward enrolling in clinical trials

    A pre-test and post-test questionnaire conducted with participants to assess any changes in attitudes and behavioral intentions related to clinical trial enrollment (assessed via 4 Likert-scale questions)

    Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention

  • Percent change in enrollment status in cancer research studies and clinical trials as measured by tracking individual enrollment statuses at the time of intervention and after education

    Actual enrollment into a clinical trial or cancer research study will be assessed via Dartmouth Cancer Center (DCC) Office of Clinical Research enrollment records over 6 months post-intervention. Enrollment records for specified DCC trials/research studies will also be assessed, and change in enrollment status in cancer research or clinical trials will be measured by direct participant's active status in cancer research or clinical trials project participation.

    Tracking from time of study participation in educational intervention and following study participants for six months monitoring change in enrollment status in cancer research and clinical trials

Study Arms (2)

Arm 1

EXPERIMENTAL

Our study will be largely advertised to DCC's patients and caregivers via electronic provider portal BPA. Providers will provide prospective participants with a link to an online survey where they can consent, complete eligibility screening, the pretest, and contact information.

Other: Electronic portal education

Arm 2

EXPERIMENTAL

People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via a geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.

Other: Online educational video

Interventions

Participants will receive education via an electronic portal covering the key messages pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.

Arm 1

Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Participants will come from Dartmouth Cancer Center electronic provider portal EDH/Epic. They will receive an invitation to participate in this research study only after accessing a Qualtrics survey.
  • \- Participants must be a resident of one of the RUCC 7-9 counties in NH or VT: Coos, Sullivan Counties in New Hampshire, or Caledonia, Windsor, Windham, Orange, Orleans, Lamoille or Essex Counties in Vermont. They will be invited to participate in the study through social media, listservs, or from flyers in community settings.

You may not qualify if:

  • \- Cognitive impairment preventing participation in informed consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Judith R Rees, BM, BCh, MPH, PhD

    Geisel School of Medicine at Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement

Study Record Dates

First Submitted

May 15, 2020

First Posted

June 1, 2020

Study Start

October 31, 2020

Primary Completion

November 3, 2023

Study Completion

November 3, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations