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Promoting Cancer Symptom Management in Older Adults

Not Applicable
Completed
Conditions
Chemotherapy-induced Nausea and Vomiting
Neoplasms
Interventions
Other: eSSET-CINV
Registration Number
NCT03143829
Lead Sponsor
University of Central Florida
Brief Summary

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupeSSET-CINVelectronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
Wait Control groupeSSET-CINVThe 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.
Primary Outcome Measures
NameTimeMethod
Symptom Severity Change Over Timeassessed 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

Self-management Behaviors Over Timedata 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.

Health-related Quality of Life Change Over Timeassessed 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

Resource Use Over Timeassessed 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Orlando Health

🇺🇸

Orlando, Florida, United States

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