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Promoting Cancer Symptom Management in Older Adults

NCT ID: NCT03143829

Last Updated: 2021-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-11

Study Completion Date

2018-08-31

Brief Summary

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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

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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

Conditions

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Neoplasms Chemotherapy-induced Nausea and Vomiting

Keywords

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gerontology symptom self-management Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

eSSET-CINV

Intervention Type 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.

Wait Control group

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.

Group Type ACTIVE_COMPARATOR

eSSET-CINV

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Managing at home: CINV

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role collaborator

Orlando Health, Inc.

OTHER

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Loerzel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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Orlando Health

Orlando, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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1R15NR015851-01

Identifier Type: NIH

Identifier Source: org_study_id

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