Malignant Female Reproductive System NeoplasmNCT07608445
Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients
A study testing Educational Intervention, Goal Setting and Interview in people with Malignant Female Reproductive System Neoplasm, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- Educational Intervention, Goal Setting and Interview
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2026to 26 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
Jessica Cheng, 626-218-4673, jescheng@coh.org
City of Hope at Irvine Lennar
Irvine, California, 92618
Jessica Cheng, 949-759-2863, jescheng@coh.org
Jessica Cheng
About this study
Official title: Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L.
EXPLORATORY OBJECTIVES:
- 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.
- 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.
- Being tested
- Educational Intervention, Goal Setting, Interview, Referral, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive written prehabilitation education materials
Goal SettingOther
Follow and meet prehabilitation goals
InterviewOther
Ancillary studies
ReferralOther
Also called Referred
Receive tailored multidisciplinary referrals
RehabilitationProcedure or surgery
Also called Physical Health Services / Rehabilitation, rehabilitation therapy, Rehabilitation, Medical
Attend cancer physiatry consultation
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive resistance bands, nutritional guidance sources, and tips and resources
Survey AdministrationOther
Ancillary studies
Tailored InterventionProcedure or surgery
Receive starter prescription
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (physiatry-led prehabilitation) | Experimental | 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. Receives: Other: Educational Intervention; Other: Goal Setting; Other: Interview; Other: Referral; Procedure: Rehabilitation; Other: Supportive Care; Other: Survey Administration; Procedure: Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant completion and adherence to the prescribed training program (Feasibility)
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).
Measured: Up to 28 days immediately prior to surgery
Secondary outcomes (14)
Enrollment rate (Feasibility)
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).
Measured: Up to 1 year
Change in physical measures - Six Minute Walk Test (6MWT)
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in physical measures - Duke Activity Status Index (DASI)
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in physical measures - 30-second Sit to Stand (30STS)
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in physical measures - Short Physical Performance Battery (SPPB)
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in physical measures - Reported Outcomes Measurement Information System (PROMS) Cancer Function Brief 3D Profile
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in physical measures - Body composition
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.
Measured: From Baseline up to 21-35 days post-surgery
Change in exercise behavior measures - Godin-Shephard Leisure-Time Physical Activity Questionnaire
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.
Measured: From Baseline to 21-35 days post-surgery
Change in exercise behavior measures - Self-reported exercise activity
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.
Measured: From Baseline to 21-35 days post-surgery
Change in exercise behavior measures - Self-Efficacy for Home Exercise Programs (SEHEPS)
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.
Measured: From Baseline to 21-35 days post-surgery
Change in malnutrition risk
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.
Measured: Baseline to 21-35 days post-surgery
Change in psychological and spiritual distress
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.
Measured: Baseline to 21-35 days post-surgery
Change in symptom burden
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.
Measured: Baseline to 21-35 days post-surgery
Change in health-related quality of life
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.
Measured: Baseline to 21-35 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start13 Nov 2026 (estimated)
- Primary completion26 Nov 2027 (estimated)
- Study completion26 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Cheng, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608445
- Sponsor's protocol ID
- 24765
- Other IDs
- P30CA033572, NCI-2026-03209, 24765
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07608445
- Acronym / sponsor ID
- 24765
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 26 Nov 2027 (estimated)
- Study completion
- 26 Nov 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
- Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L.
EXPLORATORY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (physiatry-led prehabilitation) | Experimental | Other: Educational Intervention, Other: Goal Setting, Other: Interview, Other: Referral, Procedure: Rehabilitation, Other: Supportive Care, Other: Survey Administration, Procedure: Tailored InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive written prehabilitation education materials | Other | Supportive care (physiatry-led prehabilitation) |
| Goal SettingFollow and meet prehabilitation goals | Other | Supportive care (physiatry-led prehabilitation) |
| InterviewAncillary studies | Other | Supportive care (physiatry-led prehabilitation) |
| ReferralAlso: ReferredReceive tailored multidisciplinary referrals | Other | Supportive care (physiatry-led prehabilitation) |
| RehabilitationAlso: Physical Health Services / Rehabilitation, rehabilitation therapy, Rehabilitation, MedicalAttend cancer physiatry consultation | Procedure or surgery | Supportive care (physiatry-led prehabilitation) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive resistance bands, nutritional guidance sources, and tips and resources | Other | Supportive care (physiatry-led prehabilitation) |
| Survey AdministrationAncillary studies | Other | Supportive care (physiatry-led prehabilitation) |
| Tailored InterventionReceive starter prescription | Procedure or surgery | Supportive care (physiatry-led prehabilitation) |
Primary outcome
Participant completion and adherence to the prescribed training program (Feasibility)
Time frame: 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).
14 secondary outcomes
Enrollment rate (Feasibility)
Time frame: Up to 1 year
Change in physical measures - Six Minute Walk Test (6MWT)
Time frame: From Baseline up to 21-35 days post-surgery
Change in physical measures - Duke Activity Status Index (DASI)
Time frame: From Baseline up to 21-35 days post-surgery
Change in physical measures - 30-second Sit to Stand (30STS)
Time frame: From Baseline up to 21-35 days post-surgery
Change in physical measures - Short Physical Performance Battery (SPPB)
Time frame: From Baseline up to 21-35 days post-surgery
Change in physical measures - Reported Outcomes Measurement Information System (PROMS) Cancer Function Brief 3D Profile
Time frame: From Baseline up to 21-35 days post-surgery
Change in physical measures - Body composition
Time frame: From Baseline up to 21-35 days post-surgery
Change in exercise behavior measures - Godin-Shephard Leisure-Time Physical Activity Questionnaire
Time frame: From Baseline to 21-35 days post-surgery
Change in exercise behavior measures - Self-reported exercise activity
Time frame: From Baseline to 21-35 days post-surgery
Change in exercise behavior measures - Self-Efficacy for Home Exercise Programs (SEHEPS)
Time frame: From Baseline to 21-35 days post-surgery
Change in malnutrition risk
Time frame: Baseline to 21-35 days post-surgery
Change in psychological and spiritual distress
Time frame: Baseline to 21-35 days post-surgery
Change in symptom burden
Time frame: Baseline to 21-35 days post-surgery
Change in health-related quality of life
Time frame: Baseline to 21-35 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Cheng principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Goal Setting and Interview in people with Malignant Female Reproductive System Neoplasm, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant completion and adherence to the prescribed training program (Feasibility) (time frame: Up to 28 days immediately prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.