Promoting Cancer Symptom Management in Older Adults

University of Central Florida80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neoplasms Chemotherapy-induced Nausea and Vomiting

Interventions

eSSET-CINVOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Orlando Health

Orlando, Florida, United States

Outcomes

Primary Outcomes

Symptom Severity Change Over Time

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

Time frame: 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

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.

Time frame: 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

The EORTC-30\[21\] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome

Time frame: 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

Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.

Time frame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants

Data from ClinicalTrials.gov

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