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Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?

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ClinicalTrials.gov Identifier: NCT02468245
Recruitment Status : Recruiting
First Posted : June 10, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kelly Morris, RN, Bassett Healthcare

Brief Summary:
This study is being conducted by Bassett Healthcare Network in coordination with Bassett Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider consent to this study. This study will try to establish if nursing interventions can help improve patients' adherence to taking their oral chemotherapies as prescribed by their doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer diagnoses. Adherence to the prescribed treatment plan is very important to gain the best response to these types of treatments. The study will examine if nursing intervention via weekly phone calls may help improve adherence to oral chemotherapy treatment plans.

Condition or disease Intervention/treatment Phase
Antineoplastic Agents Behavioral: weekly telephone follow up Behavioral: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Control Arm
This is a "usual care" group. Patients in this arm will receive the standard pre-drug initiation training and 4 week clinic follow up visit.
Behavioral: usual care
The control group will receive the standard chemotherapy education and will return for the standard 4 week follow up clinic visit.

Experimental: Intervention arm
Patients in this arm will also receive the standard pre-drug initiation training followed by telephone follow up by an oncology certified chemotherapy nurse (OCN) at week one, two, and three. Patients will then have the standard 4 week follow up clinic visit.
Behavioral: weekly telephone follow up
For the study group, at the initial education visit, a time for each phone call that is convenient for the patient will be scheduled. At each phone call, the OCN will get a pill count and discuss reasons for missed doses if applicable; grade any AE's experienced and interventions for those side effects; and answer any questions or concerns that they patient may be having. Patients will then return for the standard 4 week clinic visit.




Primary Outcome Measures :
  1. Oral chemotherapy compliance [ Time Frame: 4 weeks ]
    A 4 week pill count will be completed on all participants to measure drug compliance.



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

Inclusion Criteria:

  • Must be >= 18 years of age
  • Have a diagnosis of Cancer that will require an oral chemotherapy
  • Be treated at Bassett Medical Center Cancer Center
  • Must not be receiving radiation or infusional chemotherapy concomitantly with their oral chemotherapy

Exclusion Criteria:

  • Being treated at satellite sites
  • Receiving radiation and/or infusional chemotherapy concurrently with oral chemotherapy
  • Due to impairment or other reasons, patient unable to provide consent or comply with survey.

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): NCT02468245


Contacts
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Contact: jennifer victory, RN 607-547-6965 jennifer.victory@bassett.org

Locations
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United States, New York
Bassett Healthcare Network Recruiting
Cooperstown, New York, United States, 13326
Contact: Jennifer Victory, RN    607-547-6965    jennifer.victory@bassett.org   
Principal Investigator: Kelly Morris, RN         
Sponsors and Collaborators
Bassett Healthcare
Investigators
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Principal Investigator: kelly morris, RN Bassett Healthcare
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Responsible Party: Kelly Morris, RN, Nurse Manager, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02468245    
Other Study ID Numbers: 1096
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by Kelly Morris, RN, Bassett Healthcare:
Nursing intervention
compliance