The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

October 15, 2020 updated by: Theresa Jabaley, Dana-Farber Cancer Institute
This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research study is being done to investigate the feasibility of providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients at Dana Farber for chemotherapy. The investigators want to evaluate whether the binder is helpful and usable for patients; and its effect on knowledge.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to read, write, and converse in English.
  • 18 years or older
  • Scheduled for a new chemotherapy start (intravenous) to treat adenocarcinoma of the pancreas or colorectal cancer

Exclusion Criteria:

  • Enrolled in a clinical trial for chemotherapy
  • Major psychological diagnoses that would limit participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychoeducational intervention
  • Psychoeducational will be conducted prior to chemotherapy.
  • Teach session will occur prior and during administration of chemo
  • A small quiz will be conducted to asses understanding of the educational binder
Other: Psychoeducational
Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
An average positive direction of change scores between participants' pre- and post- knowledge scores
Time Frame: 8 weeks
8 weeks
Average score of 24 or higher on the adapted Acceptability E-scale
Time Frame: 8 weeks
8 weeks
80% or higher on the index of rates for delivery of educational binders
Time Frame: 8 weeks
8 weeks
80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders
Time Frame: 8 weeks
8 weeks
80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy
Time Frame: 8 weeks
8 weeks
80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Theresa Jabaley, PhD, RN, Dana-Farber Cancer Institute

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 Major Dates

Study Start (Actual)

July 9, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

July 3, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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