Lung Cancer
Conditions
Keywords
Lung Cancer, Telemonitoring, Rural, Nursing
Brief summary
The purpose of this study is to learn more about using a home machine Telemonitor to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.
Detailed description
All patients in the study will receive usual care after hospital discharge. This study also involves an interview and review of your medical records, and uses the telemonitor machine to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask you to press YES or NO buttons in response to questions on your symptoms such as difficulty breathing. Research nurses will come to your home 3 times and it will take about 30 minutes for each visit for the nurse to record the information using the telemonitor. You will also be asked to fill out a survey about your ability to do activities and your health status. This will take approximately another 30 minutes. You may or may not receive the small telemonitor (about as big as a large book) for 14 days after discharge to provide additional information to the researchers. If you receive the monitor for the full 14 days, you or someone you ask us to train will be taught to use the monitor every morning to collect information on how you will talk to you to tell you to put a blood pressure cuff on your arm and an oxygen measurer on your finger. You will step on a scale to take your weight and you will use a forehead sensor to take your temperature. The blood pressure, weight, temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then ask you at least 10 questions and you will push a yes or no button indicating how much difficulty you are having with your daily activities and shortness of breath. The monitor will then connect to your telephone line using a no-charge 800 number and transmit the information to the researchers. If you do not have a phone, a special antenna will be connected to the monitor to transmit the information wirelessly. The nurse will call you every day for the 14 days when you have the monitor. If you do not receive the monitor for the full 14 days, you will still have the monitor used by the nurse when you are visited at least 3 times at home to gather information on how you are doing after hospital discharge. These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and 2 months after discharge. The main difference is that the monitor will not be left in your home but will be brought by the nurse on each visit. You will also receive a phone call to ask you questions about the study at 1 month after discharge. If you do not have a phone, you will receive another home visit. Whether or not you get the monitor for the full 14 days will be determined randomly by computer before the nurse visits you at home the first time. are doing. The monitor will turn on each day at the same time; the monitor
Interventions
DEVICEHomMed Telemonitor
A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.
Sponsors
National Cancer Institute (NCI)
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
(1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2) at least 45 years of age and up to 90 years old; (3) stable mental status and ability to speak (but not necessarily read) the primary language of the region (English).
Exclusion criteria
1. are not discharged to home settings 2. are discharged to hospice 3. display a verbalized inability to understand or answer the questionnaires, (4) are disqualified at the discretion of the treating physician, and/or (4) live beyond a 75 mile radius of the hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Telemonitor Data From Baseline: Weight | 14 days | Changes in weight measured by telemonitor daily over 14 days after hospital discharge |
| Changes in Telemonitor Data From Baseline: Pulse Rate | 14 days | Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge |
| Changes in Telemonitor Data From Baseline: Blood Pressure | 14 days | Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge |
| Changes in Telemonitor Data From Baseline: SpO2 | 14 days | Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge |
| Changes in Telemonitor Data From Baseline: Temperature | 14 days | Changes in temperature measured by telemonitor daily over 14 days after hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Telemonitor Symptoms Recorded From Baseline: Functioning | 14 days | Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days. |
| Changes in Telemonitor Symptoms Recorded From Baseline: Pain | 14 days | Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days. |
| Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea | 14 days | Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from West Virginia University Ruby Memorial Hospital (WVUH) and the Mary Babb Randolph Cancer Center (MBRCC) at WVUH. The study subject recruitment began in April, 2011 and terminated at the end of December 2012.
Pre-assignment details
Two visits were needed in hospital to explain study prior to requesting consent in order to address literacy and provide opportunity for family member to be present. Time 1 data were collected at time of consent and then patients were assigned to groups prior to discharge.
Participants by arm
| Arm | Count |
|---|---|
| Telemonitor and Routine Care for Patients With lungCa PI left the institution and demographic information was not broken down into arms.
Telemonitor:
In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.
HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).
Routine care for patients with lungCa:
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 5 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Telemonitor and Routine Care for Patients With lungCa |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 47 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Changes in Telemonitor Data From Baseline: Blood Pressure
Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
Time frame: 14 days
Population: Results information was not available broken down by arm
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: Blood Pressure | Diastolic | 69.5 mmHg |
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: Blood Pressure | Systolic | 122 mmHg |
Primary
Changes in Telemonitor Data From Baseline: Pulse Rate
Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
Time frame: 14 days
Population: Results information was not available broken down by arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: Pulse Rate | 93 beats per minutes (bpm) |
Primary
Changes in Telemonitor Data From Baseline: SpO2
Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
Time frame: 14 days
Population: Results information was not available broken down by arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: SpO2 | 93.5 percentage of oxygen |
Primary
Changes in Telemonitor Data From Baseline: Temperature
Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
Time frame: 14 days
Population: Results information was not available broken down by arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: Temperature | 97.05 Degrees Fahrenheit |
Primary
Changes in Telemonitor Data From Baseline: Weight
Changes in weight measured by telemonitor daily over 14 days after hospital discharge
Time frame: 14 days
Population: Results information was not available broken down by arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Data From Baseline: Weight | 161.5 pounds |
Secondary
Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea | 3.8 score on a scale |
| Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea | 2 score on a scale |
Secondary
Changes in Telemonitor Symptoms Recorded From Baseline: Functioning
Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Functioning | 3.6 score on a scale |
| Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Functioning | 3.2 score on a scale |
Secondary
Changes in Telemonitor Symptoms Recorded From Baseline: Pain
Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemonitor and Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Pain | 2.8 score on a scale |
| Routine Care for Patients With lungCa | Changes in Telemonitor Symptoms Recorded From Baseline: Pain | 2.8 score on a scale |