Advanced Ovarian CarcinomaNCT05047926
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
A study testing Behavioral Counseling, Nutritional Supplement Drink and Physical Activity in people with Advanced Ovarian Carcinoma and Stage IIIC Fallopian Tube Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Ovarian Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8
- What is being tested?
- Behavioral Counseling, Nutritional Supplement Drink and Physical Activity
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 8 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis
- Suspected Stage IIIC or IV disease based on clinician staging and imaging
- Curative intent treatment with platinum-based chemotherapy
- Planned surgical intervention at some point during treatment course
- Ability to read English
Show all 9Show fewer
- No diagnosed severe cognitive impairment
- Ability to provide consent
- Ability to utilize technology to watch online modules for the Resilient Living Program
Who cannot join
- Hemiplegia or paraplegia
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prehabilitation for Advanced Ovarian Cancer Patients
This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.
II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.
EXPLORATORY OBJECTIVE:
- Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT 1: Patients undergoing primary surgical intervention complete surveys, undergo computed tomography (CT), and undergo collection of blood samples at baseline.
COHORT 2: Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
COHORT 3: Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
- Conditions
- Advanced Ovarian Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8
- Being tested
- Behavioral Counseling, Nutritional Supplement Drink, Physical Activity, Survey Administration, Computed Tomography
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral CounselingBehavioural
Also called Behavior Counseling, Behavioral Psychotherapy
Undergo behavioral counseling
Nutritional Supplement DrinkDietary supplement
Also called Boost, Ensure, Polymeric Enteral Nutrition Formula
Given Boost or Ensure
Physical ActivityOther
Complete physical activity assignments
Survey AdministrationOther
Complete surveys
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography
Undergo CT scans
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood collection
Health EducationBehavioural
Complete Resilient Living program
Medical Device Usage and EvaluationOther
Wear a FitBit
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (surveys, CT, blood samples) | Experimental | Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline. Receives: Other: Survey Administration; Procedure: Computed Tomography; Procedure: Biospecimen Collection |
| Cohort 2 (exercise, supplement, Resilient Living) | Experimental | Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial. Receives: Dietary Supplement: Nutritional Supplement Drink; Other: Physical Activity; Other: Survey Administration; Procedure: Computed Tomography; Behavioral: Health Education |
| Cohort 3 (exercise, supplement, coaching, Resilient Living) | Experimental | Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study. Receives: Behavioral: Behavioral Counseling; Dietary Supplement: Nutritional Supplement Drink; Other: Physical Activity; Other: Survey Administration; Behavioral: Health Education; Other: Medical Device Usage and Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
Assessed based on patient reported adherence in Cohort 2. For cohort 3, adherence will be documented in MyDataHelps® and monitored remotely by the study team on the Care Evolution platform®. Participants will be evaluated weekly for compliance with the recommended exercise and nutrition and resilience interventions. Documentation of adherence will be through online patient messages, phone call, or during in person visits, whichever the patient prefers
Measured: Weekly up to 4 months
Secondary outcomes (9)
Implementation outcome
Ability to recruit to this type of study and perform assessments at our institution will be measured based on the number of patients enrolled and the number of assessments completed throughout the study.
Measured: Up to 4 months
Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2
Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.
Measured: Baseline
Change of Short Physical Performance Battery (SPPB) over time in cohort 2
The Short Physical Performance Battery (SPPB) assessment will be administered and scored at baseline and at each study visit to assess lower extremity functioning (balance, gait, standing up from a chair).
Measured: Up to 4 months
Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2
The following assessment tools will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Short Physical Performance Battery (SPPB); gait speed (measured in meters/second); patient reported outcomes through Patient-Reported Outcomes Measurement Information System (PROMIS) short form surveys in the domains of pain, physical function, anxiety, emotional support, and fatigue; perceived stress scale; Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale.
Measured: Baseline, up to 4 months
Correlation of assessments to compliance with interventions in cohort 2
The following assessment tools will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Short Physical Performance Battery (SPPB); gait speed (measured in meters/second); patient reported outcomes through Patient-Reported Outcomes Measurement Information System (PROMIS) short form surveys in the domains of pain, physical function, anxiety, emotional support, and fatigue; perceived stress scale; Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale.
Measured: Baseline, up to 4 months
Correlation of frailty assessments with clinical judgement of frailty
The following assessments will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale. Results from these will be compared for correlation.
Measured: Baseline, up to 4 months
Correlation of body composition on computed tomography (CT) scans to frailty assessments
The following assessments will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale. Results from these will be compared for correlation.
Measured: Baseline, up to 4 months
Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens
Qualitative data from weekly contacts and exit interviews will be analyzed for codes and organized in themes to elucidate barriers, facilitators, perceived benefits, and negative effects of the program.
Measured: Baseline, up to 4 months
Acceptability of remote setting in Cohort 3
Assessed using an Acceptability Questionnaire, which consists of 6 questions answered on a scale of 1-10 where 1=not at all and 10=extremely.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start5 Oct 2021
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanika A. Kumar, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047926
- Sponsor's protocol ID
- 21-005226
- Other IDs
- NCI-2021-09494
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Advanced Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT05047926
- Acronym / sponsor ID
- 21-005226
- Conditions
- Advanced Ovarian Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 17 Sep 2021 (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 evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.
II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.
EXPLORATORY OBJECTIVE:
- Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT 1: Patients undergoing primary surgical intervention complete surveys, undergo computed tomography (CT), and undergo collection of blood samples at baseline.
COHORT 2: Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.
COHORT 3: Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (surveys, CT, blood samples) | Experimental | Other: Survey Administration, Procedure: Computed Tomography, Procedure: Biospecimen CollectionPatients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline. |
| Cohort 2 (exercise, supplement, Resilient Living) | Experimental | Dietary Supplement: Nutritional Supplement Drink, Other: Physical Activity, Other: Survey Administration, Procedure: Computed Tomography, Behavioral: Health EducationPatients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial. |
| Cohort 3 (exercise, supplement, coaching, Resilient Living) | Experimental | Behavioral: Behavioral Counseling, Dietary Supplement: Nutritional Supplement Drink, Other: Physical Activity, Other: Survey Administration, Behavioral: Health Education, Other: Medical Device Usage and EvaluationPatients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 years old
- Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis
- Suspected Stage IIIC or IV disease based on clinician staging and imaging
- Curative intent treatment with platinum-based chemotherapy
- Planned surgical intervention at some point during treatment course
Key exclusion criteria (2 listed)
- Hemiplegia or paraplegia
- Current pregnancy
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 |
|---|---|---|
| Behavioral CounselingAlso: Behavior Counseling, Behavioral PsychotherapyUndergo behavioral counseling | Behavioural | Cohort 3 (exercise, supplement, coaching, Resilient Living) |
| Nutritional Supplement DrinkAlso: Boost, Ensure, Polymeric Enteral Nutrition FormulaGiven Boost or Ensure | Dietary supplement | Cohort 2 (exercise, supplement, Resilient Living), Cohort 3 (exercise, supplement, coaching, Resilient Living) |
| Physical ActivityComplete physical activity assignments | Other | Cohort 2 (exercise, supplement, Resilient Living), Cohort 3 (exercise, supplement, coaching, Resilient Living) |
| Survey AdministrationComplete surveys | Other | Cohort 1 (surveys, CT, blood samples), Cohort 2 (exercise, supplement, Resilient Living), Cohort 3 (exercise, supplement, coaching, Resilient Living) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomographyUndergo CT scans | Procedure or surgery | Cohort 1 (surveys, CT, blood samples), Cohort 2 (exercise, supplement, Resilient Living) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood collection | Procedure or surgery | Cohort 1 (surveys, CT, blood samples) |
| Health EducationComplete Resilient Living program | Behavioural | Cohort 2 (exercise, supplement, Resilient Living), Cohort 3 (exercise, supplement, coaching, Resilient Living) |
| Medical Device Usage and EvaluationWear a FitBit | Other | Cohort 3 (exercise, supplement, coaching, Resilient Living) |
Primary outcome
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
Time frame: Weekly up to 4 months
Assessed based on patient reported adherence in Cohort 2. For cohort 3, adherence will be documented in MyDataHelps® and monitored remotely by the study team on the Care Evolution platform®. Participants will be evaluated weekly for compliance with the recommended exercise and nutrition and resilience interventions. Documentation of adherence will be through online patient messages, phone call, or during in person visits, whichever the patient prefers
9 secondary outcomes
Implementation outcome
Time frame: Up to 4 months
Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2
Time frame: Baseline
Change of Short Physical Performance Battery (SPPB) over time in cohort 2
Time frame: Up to 4 months
Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2
Time frame: Baseline, up to 4 months
Correlation of assessments to compliance with interventions in cohort 2
Time frame: Baseline, up to 4 months
Correlation of frailty assessments with clinical judgement of frailty
Time frame: Baseline, up to 4 months
Correlation of body composition on computed tomography (CT) scans to frailty assessments
Time frame: Baseline, up to 4 months
Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens
Time frame: Baseline, up to 4 months
Acceptability of remote setting in Cohort 3
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Amanika A. Kumar, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Counseling, Nutritional Supplement Drink and Physical Activity in people with Advanced Ovarian Carcinoma and Stage IIIC Fallopian Tube Cancer AJCC v8, run by Mayo Clinic at 1 site 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3) (time frame: Weekly up to 4 months). 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 8 Aug 2025.