NCT00932490

Brief Summary

The primary aim of study is to:

  1. 1.Test the effectiveness of a tailored protocol in promoting adherence to oral chemotherapeutic agents in adults receiving a new oral chemotherapeutic agent for breast, colorectal, GIST, renal cell,and hepatocellular cancers.
  2. 2.Examine adherence to oral chemotherapeutic agents over time at 2, 4 and 6 months in a sample of breast, colorectal, GIST, renal cell,and HPCC cancers patients.
  3. 3.Examine the effects of age, gender, caregiver availability, personal involvement in health care, and depression on adherence to oral chemotherapeutic agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable cancer

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

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 15, 2014

Status Verified

November 1, 2012

Enrollment Period

2.5 years

First QC Date

July 2, 2009

Last Update Submit

July 14, 2014

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Adherence to Oral Chemotherapy Medication

    2, 4, & 6 months

Study Arms (2)

Nurse Coaching

EXPERIMENTAL

Tailored adherence intervention that will be based on the particular needs of patients and an advanced practice nurse will suggest individualized strategies to overcome barriers to adherence

Behavioral: Nurse Coaching

Control

NO INTERVENTION

Interventions

Nurse CoachingBEHAVIORAL

Tailored adherence intervention that will be based on the particular needs of patients and advanced practice nurses will suggest individualized strategies to overcome barriers to adherence

Nurse Coaching

Eligibility Criteria

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

You may qualify if:

  • a diagnosis of Breast, Colorectal, GIST, Renal, HPCC, Myeloma and Chronic Leukemia
  • years or older
  • a treatment regimen that includes at least one oral chemotherapeutic agent
  • ability to read and write English
  • ability to give informed consent
  • ability to have prescriptions for oral chemotherapy filled at the Duke University Medical Center pharmacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Schneider SM, Hess K, Gosselin T. Interventions to promote adherence with oral agents. Semin Oncol Nurs. 2011 May;27(2):133-41. doi: 10.1016/j.soncn.2011.02.005.

    PMID: 21514482BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Susan M Schneider, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 15, 2014

Record last verified: 2012-11

Locations

US(1)