Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Primary Purpose
Advanced Ovarian Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Counseling
Nutritional Supplement Drink
Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Ovarian Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional (physical activity, supplements, counseling)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05047926
Brief Title
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Official Title
Prehabilitation for Advanced Ovarian Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional (physical activity, supplements, counseling)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Counseling
Other Intervention Name(s)
Behavior Counseling, Behavioral Psychotherapy
Intervention Description
Undergo behavioral counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement Drink
Other Intervention Name(s)
Boost, Ensure, Polymeric Enteral Nutrition Formula
Intervention Description
Given Boost or Ensure
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
Complete physical activity assignments
Primary Outcome Measure Information:
Title
Adherence to each prehabilitation component based on patient reported adherence in cohort 2
Description
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.
Time Frame
Weekly up to 4 months
Secondary Outcome Measure Information:
Title
Implementation outcome
Description
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.
Time Frame
Up to 4 months
Title
Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2
Description
Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.
Time Frame
Baseline
Title
Change of Short Physical Performance Battery (SPPB) over time in cohort 2
Description
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).
Time Frame
Up to 4 months
Title
Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2
Description
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.
Time Frame
Baseline, up to 4 months
Title
Correlation of assessments to compliance with interventions in cohort 2
Description
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.
Time Frame
Baseline, up to 4 months
Title
Correlation of frailty assessments with clinical judgement of frailty
Description
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.
Time Frame
Baseline, up to 4 months
Title
Correlation of body composition on computed tomography (CT) scans to frailty assessments
Description
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.
Time Frame
Baseline, up to 4 months
Title
Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens
Description
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.
Time Frame
Baseline, up to 4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanika A Kumar
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Amanika A. Kumar, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
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