Promoting Cancer Symptom Management in Older Adults

NCT03143829 | Completed Results DMC

• 1 other identifier: 1R15NR015851-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Chemotherapy-induced Nausea and Vomiting

Keywords

gerontology; symptom self-management; Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment

Other: eSSET-CINV

Wait Control group

ACTIVE COMPARATOR

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

Interventions

eSSET-CINV OTHER

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.

Also known as: Managing at home: CINV

Intervention group; Wait Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Florida: lead
• University of South Florida: collaborator
• Orlando Health, Inc.: collaborator

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations were noted with the Cognitive representation data. Participants in this study had very little nausea and therefore were inconsistent in how and when they completed this instrument making data analysis unreliable.

Results Point of Contact

• Title: Victoria Loerzel
• Organization: University of Central Floroda

victoria.loerzel@ucf.edu

407-823-0762

Study Officials

• Victoria Loerzel, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 8, 2017
• Study Start: August 11, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 29, 2021
• Results First Posted: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)