Promoting Cancer Symptom Management in Older Adults

Neoplasms Clinical Trial

Official title:

Promoting Cancer Symptom Management in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143829
• Other study ID #: 1R15NR015851-01
• Status: Completed
• Phase: N/A
• Start date: August 11, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2021
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Neoplasms
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Central Florida	Orlando Health, Inc., University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Primary	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.	data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
Primary	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	assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
Primary	Resource Use Over Time	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