Clinical trial NCT03143829: Promoting Cancer Symptom Management in Older Adults
Official title: Promoting Cancer Symptom Management in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Chemotherapy-induced Nausea and Vomiting
Keywords: gerontology
symptom self-management
Chemotherapy-induced Nausea and Vomiting
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Orlando Health, Inc.
First posted: 2017-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom Severity Change Over Time
timeFrame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
measure: Self-management Behaviors Over Time
timeFrame: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
measure: Health-related Quality of Life Change Over Time
timeFrame: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
measure: Resource Use Over Time
timeFrame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: University of Central Florida
name: Victoria Loerzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: