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

NCT02468245 | Unknown

• 1 other identifier: 1096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Antineoplastic Agents

Keywords

Nursing intervention; compliance

Outcome Measures

Primary Outcomes (1)

• Oral chemotherapy compliance

  A 4 week pill count will be completed on all participants to measure drug compliance.

  4 weeks

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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

Intervention arm

EXPERIMENTAL

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

Interventions

weekly telephone follow up BEHAVIORAL

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.

Intervention arm

usual care BEHAVIORAL

The control group will receive the standard chemotherapy education and will return for the standard 4 week follow up clinic visit.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristina Loeffler, RN

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Manager

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 10, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

US (1)