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The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576872
Enrollment
49
Registered
2018-07-03
Start date
2018-07-09
Completion date
2019-09-30
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Intestinal Cancer

Keywords

Gastro Intestinal Cancer

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.

Interventions

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

Sponsors

Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants8 weeks

Secondary

MeasureTime frame
Average score of 24 or higher on the adapted Acceptability E-scale8 weeks
80% or higher on the index of rates for delivery of educational binders8 weeks
An average positive direction of change scores between participants' pre- and post- knowledge scores8 weeks
80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy8 weeks
80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy8 weeks
80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026