NCT03576872

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

July 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

June 22, 2018

Last Update Submit

October 15, 2020

Conditions

Gastro Intestinal Cancer

Keywords

Gastro Intestinal Cancer

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Psychoeducational intervention

EXPERIMENTAL

* 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

Interventions

PsychoeducationalOTHER

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

Psychoeducational intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read, write, and converse in English.
  • years or older
  • Scheduled for a new chemotherapy start (intravenous) to treat adenocarcinoma of the pancreas or colorectal cancer

You may not qualify if:

  • Enrolled in a clinical trial for chemotherapy
  • Major psychological diagnoses that would limit participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Theresa Jabaley, PhD, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 3, 2018

Study Start

July 9, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)