Promoting Cancer Symptom Management in Older Adults

December 3, 2021 updated by: University of Central Florida
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women age 65 and older
  • newly diagnosed with any cancer
  • treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle)
  • proficient in English
  • have a telephone.

Exclusion Criteria:

  • Patients with previous diagnosis and treatment for cancer
  • advanced or end stage disease with a palliative intent
  • visually or hearing impaired.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
Other: eSSET-CINV
This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home.
Other Names:
  • Managing at home: CINV
Active Comparator: Wait Control group
The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.
Other: eSSET-CINV
This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home.
Other Names:
  • Managing at home: CINV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Severity Change Over Time
Time Frame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Symptom Representation Questionnaire (SRQ)[20] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome
assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Self-management Behaviors Over Time
Time Frame: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management.
data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
Health-related Quality of Life Change Over Time
Time Frame: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
The EORTC-30[21] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
Resource Use Over Time
Time Frame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Collaborators

University of South Florida
Orlando Health, Inc.

Investigators

  • Principal Investigator: Victoria Loerzel, PhD, University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2016

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R15NR015851-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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