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

Study Overview
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Brief Summary
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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
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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 complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo behavioral counseling for 60 minute on days 21 and 30 post surgery.

Official Title
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Prehabilitation for Advanced Ovarian Cancer Patients

Conditions
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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, Stage IV Primary Peritoneal Cancer AJCC v8

Intervention / Treatment
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* Behavioral: Behavioral Counseling
* Dietary Supplement: Nutritional Supplement Drink
* Other: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional (physical activity, supplements, counseling)<br>Patients complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo behavioral counseling for 60 minute on days 21 and 30 post surgery. | Behavioral: Behavioral Counseling<br>* Undergo behavioral counseling<br>* Other names: Behavioral Psychotherapy;Dietary Supplement: Nutritional Supplement Drink<br>* Given Boost or Ensure<br>* Other names: Polymeric Enteral Nutrition Formula;Other: Physical Activity<br>* Complete physical activity assignments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to each prehabilitation component based on patient reported adherence in cohort 2 | We will evaluate patients weekly for their 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. | Weekly up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | Baseline, up to 4 months |