The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Not Applicable

Completed

• Conditions: Gastro Intestinal Cancer
• Interventions: Other: Psychoeducational

• Registration Number: NCT03576872
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy

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 Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-07-03
• Study Start: 2018-07-09
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychoeducational intervention	Psychoeducational	* 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

Primary Outcome Measures

Name	Time	Method
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States