Promoting Cancer Symptom Management in Older Adults

Study Overview
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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

Official Title
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Promoting Cancer Symptom Management in Older Adults

Conditions
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Neoplasms, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Other: eSSET-CINV


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment | Other: eSSET-CINV<br>* 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.<br>* Other names: Managing at home: CINV;|
| Active Comparator: Wait Control group<br>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<br>* 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.<br>* Other names: Managing at home: CINV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting