Promoting Cancer Symptom Management in Older Adults

• Sponsor: University of Central Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03143829
• Collaborator: University of South Florida (Other), Orlando Health, Inc. (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Chemotherapy-induced Nausea and Vomiting	Other: eSSET-CINV	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Supportive Care
• Official Title: Promoting Cancer Symptom Management in Older Adults
• Actual Study Start Date: Aug 11, 2016
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment	Other: 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.; Other Names: Managing at home: CINV
Active Comparator: 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.	Other: 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.; Other Names: Managing at home: CINV

Outcome Measures

Primary Outcome Measures

1. Symptom Severity Change Over Time [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Health	Orlando	Florida	United States	32806

Sponsors and Collaborators

• University of Central Florida
• University of South Florida
• Orlando Health, Inc.

Investigators

• Principal Investigator: Victoria Loerzel, PhD, University of Central Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 9, 2021

More Information

Publications

None provided.

• Responsible Party: University of Central Florida
• ClinicalTrials.gov Identifier: NCT03143829
• Other Study ID Numbers: 1R15NR015851-01
• First Posted: May 8, 2017
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Central Florida: gerontology; symptom self-management; Chemotherapy-induced Nausea and Vomiting
• Additional relevant MeSH terms: Nausea; Vomiting

Study Results

Participant Flow

Recruitment Details	Recruitment took place from June 2016 through August 2018 at the outpatient treatment center at the cancer center

Arm/Group Title	Intervention Group	Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.
Period Title: Overall Study
STARTED	38	42
COMPLETED	33	32
NOT COMPLETED	5	10

Baseline Characteristics

Arm/Group Title	Intervention Group	Wait Control Group	Total
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.	Total of all reporting groups
Overall Participants	38	42	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.11 (5.311)	70.26 (6.012)	69.71 (5.684)
Sex: Female, Male (Count of Participants)
Female	29 76.3%	30 71.4%	59 73.8%
Male	9 23.7%	12 28.6%	21 26.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	3 7.1%	3 3.8%
Not Hispanic or Latino	38 100%	39 92.9%	77 96.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 5.3%	2 4.8%	4 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.6%	4 9.5%	5 6.3%
White	35 92.1%	34 81%	69 86.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 4.8%	2 2.5%
Region of Enrollment (participants) [Number]
United States	38 100%	42 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Symptom Severity Change Over Time
Description	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
Time Frame	assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.
Measure Participants	38	42
Mean (Standard Deviation) [score on a scale]	4.13 (3.240)	3.81 (3.293)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Wait Control Group
	Comments	Differences at week 10
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.083
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Self-management Behaviors Over Time
Description	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.
Time Frame	data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.
Measure Participants	38	42
Mean (Standard Deviation) [Behaviors]	3.68 (7.59)	1.38 (4.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Wait Control Group
	Comments	Descriptive comparison
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.099
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Health-related Quality of Life Change Over Time
Description	The EORTC-30[21] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
Time Frame	assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.
Measure Participants	34	32
Mean (Standard Deviation) [score on a scale]	5.76 (1.046)	5.91 (.893)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Wait Control Group
	Comments	comparison at time 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.558
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Resource Use Over Time
Description	Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
Time Frame	assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.	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. 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.
Measure Participants	38	42
Number [admissions]	19	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Wait Control Group
	Comments	descriptive comparison of resource use
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.153
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention Group		Wait Control Group
Arm/Group Description	electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment 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.		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. 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.
All Cause Mortality
	Intervention Group		Wait Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/38 (2.6%)		1/42 (2.4%)
Serious Adverse Events
	Intervention Group		Wait Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Wait Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/42 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.