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Completed

NCT Number: NCT03576872

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

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

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Key information

Conditions

Gastro Intestinal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational

Other

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

Primary outcomes

  1. 80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  3. 80% or higher on the index of rates for delivery of educational binders

    Time frame: 8 weeks

  4. 80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders

    Time frame: 8 weeks

  5. 80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy

    Time frame: 8 weeks

  6. 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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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