Malignant Female Reproductive System Neoplasm
Conditions
Brief summary
This clinical trial studies whether physiatry-led cancer prehabilitation can be used during systemic treatment before surgery (neoadjuvant systemic treatment \[NST\]) to improve function in stage III-IVA gynecologic cancer patients. Treatment of gynecologic cancers presents significant challenges to physical and mental health and patients often experience many challenges following treatment including sleep disturbance, extreme tiredness, sexual dysfunction, and bowel and urinary problems. Patients who have low functioning prior to surgery often have worse outcomes following surgery; however, services to support functional shortages often start after surgery. Physiatry-led cancer prehabilitation is a strategy aimed at reducing post-treatment functional challenges by improving physical and mental function before treatment. It involves physiatry, which is a medical specialty focused on function. Physiatry involvement in prehabilitation allows for the evaluation and management of co-existing conditions, medical supervision, and the coordination of complex plans involving multiple teams. Using physiatry-led cancer prehabilitation during NST may be an effective way to improve function in stage III-IVA gynecologic cancer patients.
Detailed description
PRIMARY OBJECTIVES: I. Determine feasibility based on adherence (\> 70%) across the key components-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in \> 70% of enrolled patients for the 28-day period immediately prior to surgery. II. Evaluate feasibility via enrollment rate \> 50% of eligible patients. SECONDARY OBJECTIVES: I. Evaluate physical measures: Six Minute Walk Test, Duke Activity Status Index, 30-second Sit to Stand, Short Physical Performance Battery, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief Three Domains (3D) Profile, and body composition. II. Assess exercise behavior measures: Godin-Shephard Leisure-Time Physical Activity Questionnaire, self-reported exercise activity and future intent, Self-Efficacy for Home Exercise Programs. III. Evaluate malnutrition risk with Malnutrition Screening Tool. IV. Assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L). V. Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L. EXPLORATORY OBJECTIVES: I. Evaluate the impact of the tailored prehabilitation program on disease outcomes as measured by Relative Dose Intensity, pathologic complete response, Response Evaluation Criteria in Solid Tumors, and cancer antigen 125 (CA-125). II. Evaluate the impact of the tailored prehabilitation program on cancer treatment timing by examining time from diagnosis to surgery, time from last chemotherapy cycle to surgery, time from surgery to adjuvant treatment, hospitalizations and length of stay. III. Evaluate the impact of the tailored prehabilitation program on cancer treatment complications, measured by the incidence of chemotherapy-induced peripheral neuropathy (using Common Terminology Criteria for Adverse Events \[CTCAE\] 5.0) and 30-day readmission rate. IV. Identify future program improvements via a participant feedback survey and/or interview, clinician feedback survey and/or interview, reasons for non-participation, challenges to intervention adherence, and days to consult completion. V. Document the utilization of multidisciplinary specialty services. OUTLINE: Patients attend a cancer physiatry consultation over 1 hour and receive an introduction to the home-based program, a starter prescription, and written prehabilitation education materials before the start of cycle 2 of NST. Patients then follow the provided starter prescription and attempt to meet aerobic exercise, resistance exercise, nutrition, and psychospiritual goals at home during and while off NST in the absence of unacceptable toxicity. Patients also attend additional cancer physiatry consultation follow-ups at 28 days and at 28 days after surgery. Additionally, patients receive resistance bands, sources for nutritional guidance, and practical tips and resources on study and may also receive tailored multidisciplinary referrals as needed.
Interventions
OTHEREducational Intervention
Receive written prehabilitation education materials
OTHERGoal Setting
Follow and meet prehabilitation goals
OTHERInterview
Ancillary studies
OTHERReferral
Receive tailored multidisciplinary referrals
PROCEDURERehabilitation
Attend cancer physiatry consultation
OTHERSupportive Care
Receive resistance bands, nutritional guidance sources, and tips and resources
OTHERSurvey Administration
Ancillary studies
PROCEDURETailored Intervention
Receive starter prescription
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* PATIENT: Documented informed consent of the participant * PATIENT: Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments * PATIENT: Age: ≥ 18 years * PATIENT: Able to read and write in English * PATIENT: A diagnosis of stage III-IVA gynecologic cancer planned for NST * PATIENT: Plan to start NST at City of Hope Orange County * HEALTHCARE TEAM: Documented informed consent of the participant * HEALTHCARE TEAM: Willingness to complete the Healthcare Worker Survey * HEALTHCARE TEAM: ≥ 18 years old * HEALTHCARE TEAM: Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care
Exclusion criteria
* PATIENT: Current or planned cancer treatment for a second cancer * PATIENT: Clinically significant uncontrolled illness limiting participation with the research intervention and assessments * PATIENT: Stage IVB cancer with distant metastases * PATIENT: Other active malignancy * PATIENT: Pregnant or breastfeeding * PATIENT: Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * PATIENT: Meeting or exceeding exercise guidelines over the last one month based on the responses from the Godin-Shephard Leisure Time Physical Activity Questionnaire (GSLTPAQ) * PATIENT: Started second cycle before the physiatry consult * PATIENT: Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.) * PATIENT: Unable to independently answer questionnaires in English * HEALTHCARE TEAM: Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant completion and adherence to the prescribed training program (Feasibility) | Up to 28 days immediately prior to surgery | Feasibility will be determined primarily by participant adherence to the prescribed training program during the 28-day period immediately prior to surgery, with the goal of \> 70% adherence across each key category-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in \> 70% of enrolled patients. Adherence will be measured via a self-reported weekly training log that will be turned in routinely to the clinical research staff. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate (Feasibility) | Up to 1 year | Secondarily, feasibility will be evaluated via enrollment rate \> 50% of eligible patients. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals). |
| Change in physical measures - Six Minute Walk Test (6MWT) | From Baseline up to 21-35 days post-surgery | This Six Minute Walk Test (6MWT) test measures the distance a patient walks in 6 minutes. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in physical measures - Duke Activity Status Index (DASI) | From Baseline up to 21-35 days post-surgery | This is a 12-question validated patient-reported outcome measure of self-reported functional capacity. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in physical measures - 30-second Sit to Stand (30STS) | From Baseline up to 21-35 days post-surgery | This is an objective measure of functional capacity and lower body functional strength assessing how many times a person can go from sitting to standing within 30 seconds. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in physical measures - Short Physical Performance Battery (SPPB) | From Baseline up to 21-35 days post-surgery | This objective assessment tool evaluates lower extremity functioning in frail older adults with good validity and reliability. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in physical measures - Reported Outcomes Measurement Information System (PROMS) Cancer Function Brief 3D Profile | From Baseline up to 21-35 days post-surgery | This is a 12-question validated patient-reported outcome measure of function in outpatient cancer rehabilitation patients. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in physical measures - Body composition | From Baseline up to 21-35 days post-surgery | Body composition measures, including but not limited to fat-free mass, fat mass, and phase angle, have been associated with cancer outcomes. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in exercise behavior measures - Godin-Shephard Leisure-Time Physical Activity Questionnaire | From Baseline to 21-35 days post-surgery | This Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ questionnaire (estimated completion time of one minute) consists of 3 self-administered questions. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in exercise behavior measures - Self-reported exercise activity | From Baseline to 21-35 days post-surgery | Self-reported exercise activity is the average exercise dose over the 1 month prior will be reported by the participant at baseline and pre-operatively. This is a 12-question patient-reported outcome measure. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in exercise behavior measures - Self-Efficacy for Home Exercise Programs (SEHEPS) | From Baseline to 21-35 days post-surgery | Self-Efficacy for Home Exercise Programs (SEHEPS) is a 12-question patient-reported outcome measure based on the Self-Efficacy for Exercise. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in malnutrition risk | Baseline to 21-35 days post-surgery | Will evaluate malnutrition risk with Malnutrition Screening Tool. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in psychological and spiritual distress | Baseline to 21-35 days post-surgery | Will assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L). Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in symptom burden | Baseline to 21-35 days post-surgery | Will evaluate symptom burden with ESAS-FS. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| Change in health-related quality of life | Baseline to 21-35 days post-surgery | Will evaluate health-related quality of life with EQ-5D-5L. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Cheng
City of Hope Medical Center
Outcome results
None listed