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

Stage IV Ovarian Cancer AJCC v8 Clinical Trial

Official title:

Prehabilitation for Advanced Ovarian Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047926
• Other study ID #: 21-005226
• Secondary ID: NCI-2021-09494
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Ovarian Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal 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

Intervention

Behavioral:
• Behavioral Counseling
Undergo behavioral counseling

Dietary Supplement:
• Nutritional Supplement Drink
Given Boost or Ensure

Other:
• Physical Activity
Complete physical activity assignments
• Survey Administration
Complete surveys

Procedure:
• Computed Tomography
Undergo CT scans
• Biospecimen Collection
Undergo blood collection

Behavioral:
• Health Education
Complete Resilient Living program

Other:
• Medical Device Usage and Evaluation
Wear a FitBit

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weekly up to 4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	30 days