Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This phase III trial compares a home-based telemonitoring program that collects symptom and daily step information to surgeon only care in improving recovery and stopping complications within 30 days after surgery in patients with gastrointestinal, genitourinary, or gynecologic cancer who are scheduled to undergo abdominal surgery. Patients may experience a decrease in functional capacity and experience symptoms like pain and fatigue after surgery, and this may change their ability to walk and function. Home-based telemonitoring of patient symptoms and their ability to walk and function after surgery may help doctors and nurses find and treat problems early, which may improve the patient's recovery and lower the number of complications after surgery.
Detailed description
PRIMARY OBJECTIVES: I. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on clinically significant changes in functional recovery (accelerometer daily step count) and related secondary patient-centered outcomes (sleep, sedentary time, symptom severity, symptom interference with daily activities). II. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on postoperative complications (Comprehensive Complications Index - CCI) and related secondary surgical outcomes (hospital readmission). III. Compare early withdrawal (dropout or loss of accelerometer device) between the comparators. IV. Explore perioperative telemonitoring care-related experiences (acceptability, technology usability, uptake/integration) among patients, families, and surgeons through qualitative focus groups and exit interviews. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (REMOTE PERIOPERATIVE TELEMONITORING CARE GROUP): Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud application (app) on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to a registered nurse (RN) when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing. GROUP II (SURGEON ONLY PERIOPERATIVE CARE GROUP): Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing. After completion of study, patients are followed up for 3-4 months.
Interventions
OTHERBest Practice
Participate in a surgeon-only perioperative care program
PROCEDUREFunctional Assessment
Complete a functional assessment
OTHERMedical Device Usage and Evaluation
Wear an actigraph
PROCEDURENutritional Assessment
Complete a nutritional assessment
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERTapCloud
Use TapCloud app
Sponsors
City of Hope Medical Center
Patient-Centered Outcomes Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) malignancies * Ability to read and understand English or Spanish * Patients across all stages of disease * There are no restrictions related to performance status or life expectancy * All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion criteria
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Step Count | Baseline up to day 14 | Will calculate percent change from preoperative baseline in daily step count during the first 2 weeks post-discharge from hospital. Will use generalized linear mixed modeling (with treatment and covariates as fixed factors, patient identification as random factor). |
| Time to Early Withdrawal | Up to 4 months | Analyzed using proportional hazards regression. |
| Qualitative Data | Up to 4 months | Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach. |
| Post-operative Complications | Up to 30 days after surgery | Assessed using the Comprehensive Complications Index (CCI) which summarizes the entire patient postoperative experience with respect to complications (on a scale from 0 to 100), and is based on the established Clavien-Dindo classification. For CCI score: Higher = worse |
| Maximum CCI | Up to 30 days post-discharge | Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Readmission | Up to 90 days post-discharge | Will be subjected to survival analysis. |
| Change in Sedentary Time | Baseline up to 4 months | Assessed using the Actigraph GT9X Link. Data capture will focus on the following: 1) number of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) cutpoints will be used to categorize sedentary time (\< 100 cpm) from light-intensity physical activity (100-1951 cpm) and moderate/vigorous intensity physical activity (\>=1952 cpm). |
| Change in General Symptoms | Baseline up to 4 months | Assessed using the MD Anderson Symptom Inventory. |
| Change in Disease-specific Symptoms | Baseline up to 4 months | Assessed using the MD Anderson Symptom Library Items. |
| Change in Sleep | Baseline up to 4 months | Assessed using the MD Anderson Symptom Inventory. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirginia Sun
City of Hope Medical Center
Participant flow
Recruitment details
398 participants were enrolled to the study, however 16 participants did not want to participate after signing consent and are considered attrition which is the reason why data analysis was done for 382 participants instead of the total consented/enrolled.
Pre-assignment details
398 participants were enrolled to the study, however 16 participants did not want to participate after signing consent and are considered attrition which is the reason why data analysis was done for 382 participants instead of the total consented/enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Group I (Telemonitoring Program, Actigraph, TapCloud) Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud app on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to an RN when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing.
Functional Assessment: Complete a functional assessment
Medical Device Usage and Evaluation: Wear an actigraph
Nutritional Assessment: Complete a nutritional assessment
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
TapCloud: Use TapCloud app | 189 |
| Group II (Surgeon-only Perioperative Care Program) Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing.
Best Practice: Participate in a surgeon-only perioperative care program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 193 |
| Total | 382 |
Baseline characteristics
| Characteristic | Group I (Telemonitoring Program, Actigraph, TapCloud) | Total | Group II (Surgeon-only Perioperative Care Program) |
|---|---|---|---|
| Age, Continuous | 60.31 year STANDARD_DEVIATION 11.72 | 60.61 year STANDARD_DEVIATION 11.43 | 60.90 year STANDARD_DEVIATION 11.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants | 130 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 245 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants | 52 Participants | 17 Participants |
| Race (NIH/OMB) White | 131 Participants | 279 Participants | 148 Participants |
| Region of Enrollment United States | 189 participants | 382 participants | 193 participants |
| Sex: Female, Male Female | 88 Participants | 183 Participants | 95 Participants |
| Sex: Female, Male Male | 101 Participants | 199 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 189 | 4 / 193 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Daily Step Count
Will calculate percent change from preoperative baseline in daily step count during the first 2 weeks post-discharge from hospital. Will use generalized linear mixed modeling (with treatment and covariates as fixed factors, patient identification as random factor).
Time frame: Baseline up to day 14
Primary
Maximum CCI
Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention.
Time frame: Up to 30 days post-discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Telemonitoring Program, Actigraph, TapCloud) | Maximum CCI | High (maximum CCI >= 15) | 14 Participants |
| Group I (Telemonitoring Program, Actigraph, TapCloud) | Maximum CCI | Low (maximum CCI < 15) | 167 Participants |
| Group I (Telemonitoring Program, Actigraph, TapCloud) | Maximum CCI | Missing due to attrition or no surgery scheduled | 8 Participants |
| Group II (Surgeon-only Perioperative Care Program) | Maximum CCI | High (maximum CCI >= 15) | 20 Participants |
| Group II (Surgeon-only Perioperative Care Program) | Maximum CCI | Low (maximum CCI < 15) | 155 Participants |
| Group II (Surgeon-only Perioperative Care Program) | Maximum CCI | Missing due to attrition or no surgery scheduled | 18 Participants |
Primary
Post-operative Complications
Assessed using the Comprehensive Complications Index (CCI) which summarizes the entire patient postoperative experience with respect to complications (on a scale from 0 to 100), and is based on the established Clavien-Dindo classification. For CCI score: Higher = worse
Time frame: Up to 30 days after surgery
Population: 398 participants were enrolled to the study, however 16 participants did not want to participate after signing consent and are considered attrition which is the reason why data analysis was done for 382 participants instead of the total consented/enrolled. These number are accurate for analysis based on the data collection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (Telemonitoring Program, Actigraph, TapCloud) | Post-operative Complications | 0 units on a scale |
| Group II (Surgeon-only Perioperative Care Program) | Post-operative Complications | 0 units on a scale |
Primary
Qualitative Data
Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.
Time frame: Up to 4 months
Primary
Time to Early Withdrawal
Analyzed using proportional hazards regression.
Time frame: Up to 4 months
Secondary
Change in Disease-specific Symptoms
Assessed using the MD Anderson Symptom Library Items.
Time frame: Baseline up to 4 months
Secondary
Change in General Symptoms
Assessed using the MD Anderson Symptom Inventory.
Time frame: Baseline up to 4 months
Secondary
Change in Sedentary Time
Assessed using the Actigraph GT9X Link. Data capture will focus on the following: 1) number of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) cutpoints will be used to categorize sedentary time (\< 100 cpm) from light-intensity physical activity (100-1951 cpm) and moderate/vigorous intensity physical activity (\>=1952 cpm).
Time frame: Baseline up to 4 months
Secondary
Change in Sleep
Assessed using the MD Anderson Symptom Inventory.
Time frame: Baseline up to 4 months
Secondary
Time to Hospital Readmission
Will be subjected to survival analysis.
Time frame: Up to 90 days post-discharge