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Completed

NCT Number: NCT03143829

Promoting Cancer Symptom Management in Older Adults

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.

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Key information

Conditions

Neoplasms Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health

Orlando, Florida, 32806, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Managing at home: CINV

Primary outcomes

  1. Symptom Severity Change Over Time

    Time frame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported

    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

  2. Self-management Behaviors Over Time

    Time frame: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported

    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.

  3. Health-related Quality of Life Change Over Time

    Time frame: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported

    The EORTC-30[21] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome

  4. Resource Use Over Time

    Time frame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants

    Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Orlando Health, Inc.
  • University of South Florida

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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