Promoting Cancer Symptom Management in Older Adults
Primary Purpose
Neoplasms, Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSSET-CINV
Sponsored by
About this trial
This is an interventional supportive care trial for Neoplasms focused on measuring gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
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.
Sites / Locations
- Orlando Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Wait Control group
Arm Description
electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
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.
Outcomes
Primary Outcome Measures
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
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.
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
Resource Use Over Time
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
Secondary Outcome Measures
Full Information
NCT ID
NCT03143829
First Posted
May 1, 2017
Last Updated
December 3, 2021
Sponsor
University of Central Florida
Collaborators
University of South Florida, Orlando Health, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03143829
Brief Title
Promoting Cancer Symptom Management in Older Adults
Official Title
Promoting Cancer Symptom Management in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2016 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
University of South Florida, Orlando Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Chemotherapy-induced Nausea and Vomiting
Keywords
gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either an intervention or wait control group. The intervention group receives an educational intervention at the start of the study. The wait control group receives the intervention at the end.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
Arm Title
Wait Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eSSET-CINV
Other Intervention Name(s)
Managing at home: CINV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Severity Change Over Time
Description
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
Title
Self-management Behaviors Over Time
Description
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
Title
Health-related Quality of Life Change Over Time
Description
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
Title
Resource Use Over Time
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Loerzel, PhD
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promoting Cancer Symptom Management in Older Adults
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