Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03576872
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Theresa Jabaley, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Gastro Intestinal Cancer Other: Psychoeducational Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2024

Arm Intervention/treatment
Experimental: Psychoeducational intervention
  • 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
Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy




Primary Outcome Measures :
  1. 80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576872


Contacts
Layout table for location contacts
Contact: Theresa Jabaley, PhD, RN 617-582-8037 Theresa_jabaley@dfci.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Theresa Jabaley, PhD, RN    617-582-8037    Theresa_jabaley@dfci.harvard.edu   
Principal Investigator: Theresa Jabaley, PhD, RN         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Theresa Jabaley, PhD, RN Dana-Farber Cancer Institute

Layout table for additonal information
Responsible Party: Theresa Jabaley, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03576872     History of Changes
Other Study ID Numbers: 18-241
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theresa Jabaley, Dana-Farber Cancer Institute:
Gastro Intestinal Cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases