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Completed

NCT Number: NCT05047926

Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal 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.

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Key information

Conditions

Advanced Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms 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 Stage IV Primary Peritoneal Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No diagnosed severe cognitive impairment
  • Ability to provide consent
  • Ability to utilize technology to watch online modules for the Resilient Living Program

Exclusion criteria

  • Hemiplegia or paraplegia
  • Current pregnancy

Treatment and study plan

Behavioral Counseling

Behavioral

Undergo behavioral counseling

Other names: Behavior Counseling, Behavioral Psychotherapy

Nutritional Supplement Drink

Dietary Supplement

Given Boost or Ensure

Other names: Boost, Ensure, Polymeric Enteral Nutrition Formula

Physical activity

Other

Complete physical activity assignments

Survey Administration

Other

Complete surveys

Computed Tomography

Procedure

Undergo CT scans

Other names: CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography, Computerized axial tomography (procedure), Computerized Tomography (CT) scan, Computerized Tomography, CT, CT Scan, tomography

Biospecimen Collection

Procedure

Undergo blood collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Health Education

Behavioral

Complete Resilient Living program

Medical Device Usage and Evaluation

Other

Wear a FitBit

Primary outcomes

  1. 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

Secondary outcomes

  1. Implementation outcome

    Time frame: Up to 4 months

    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.

  2. Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2

    Time frame: Baseline

    Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.

  3. Change of Short Physical Performance Battery (SPPB) over time in cohort 2

    Time frame: Up to 4 months

    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).

  4. Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2

    Time frame: Baseline, up to 4 months

    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.

  5. Correlation of assessments to compliance with interventions in cohort 2

    Time frame: Baseline, up to 4 months

    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.

  6. Correlation of frailty assessments with clinical judgement of frailty

    Time frame: Baseline, up to 4 months

    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.

  7. Correlation of body composition on computed tomography (CT) scans to frailty assessments

    Time frame: Baseline, up to 4 months

    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.

  8. Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens

    Time frame: Baseline, up to 4 months

    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.

  9. Acceptability of remote setting in Cohort 3

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Prehabilitation for Advanced Ovarian Cancer Patients

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2021
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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