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The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Primary Purpose

Gastro Intestinal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Psychoeducational

About this trial

This is an interventional supportive care trial for Gastro Intestinal Cancer focused on measuring Gastro Intestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychoeducational intervention

Arm Description

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

Outcomes

Primary Outcome Measures

80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants

Secondary Outcome Measures

An average positive direction of change scores between participants' pre- and post- knowledge scores

Average score of 24 or higher on the adapted Acceptability E-scale

80% or higher on the index of rates for delivery of educational binders

80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders

80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy

80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy

Full Information

NCT ID

NCT03576872

First Posted

June 22, 2018

Last Updated

October 15, 2020

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03576872

Brief Title

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Official Title

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 9, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastro Intestinal Cancer

Keywords

Gastro Intestinal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psychoeducational intervention

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Psychoeducational

Intervention Description

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

Primary Outcome Measure Information:

Title

80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

An average positive direction of change scores between participants' pre- and post- knowledge scores

Time Frame

8 weeks

Title

Average score of 24 or higher on the adapted Acceptability E-scale

Time Frame

8 weeks

Title

80% or higher on the index of rates for delivery of educational binders

Time Frame

8 weeks

Title

80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders

Time Frame

8 weeks

Title

80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy

Time Frame

8 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Theresa Jabaley, PhD, RN

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

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