The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

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

Detailed Description
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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.

Official Title
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The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Conditions
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Gastro Intestinal Cancer

Intervention / Treatment
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* Other: Psychoeducational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducational intervention<br>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<br>* Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastro Intestinal Cancer