The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Gastro Intestinal Cancer Clinical Trial

Official title:

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576872
• Other study ID #: 18-241
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Intestinal Cancer
• Gastrointestinal Neoplasms
• Intestinal Neoplasms

Intervention

Other:
• Psychoeducational
Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants		8 weeks
Secondary	An average positive direction of change scores between participants' pre- and post- knowledge scores		8 weeks
Secondary	Average score of 24 or higher on the adapted Acceptability E-scale		8 weeks
Secondary	80% or higher on the index of rates for delivery of educational binders		8 weeks
Secondary	80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders		8 weeks
Secondary	80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy		8 weeks
Secondary	80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy		8 weeks