NCT04911114

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.

Detailed description

Purpose: To assess the feasibility, preliminary efficacy, and patient perspectives of a 12-week supervised, virtually-delivered exercise and healthy eating program for women living with and beyond ovarian cancer. Hypothesis: The investigators hypothesize that the program will be feasible and will demonstrate efficacy, and that patient perspectives will be overall positive and in support of the program. Justification: Women living with and beyond ovarian cancer exercise at levels below the general population, and are at an increased risk for falls. Exercise and healthy eating programming is not a part of routine care. This project has the potential to demonstrate a feasible and relatively low-cost option for offering such programming. Objectives: the objectives of this program are: 1) Primary Objective: To measure the feasibility of delivering the BE-BALANCED program from a virtual (i.e. live video) setting. Feasibility will be evaluated per individual item based on a priori targets; 2) Secondary Objective: To evaluate the preliminary efficacy of the BE-BALANCED program; 3) Tertiary Objective: To evaluate patient satisfaction (post-intervention only) Research Design: This study is a prospective single-arm feasibility study. Statistical Analysis: The primary aim is feasibility. This will be evaluated using descriptive statistics, focusing on the program recruitment, attendance, attrition, and fidelity. For secondary and tertiary/exploratory aims, a repeated measures ANOVA will be performed for each measure to evaluate the change in outcomes from baseline and end of intervention (12-weeks) and 3-month follow-up. In addition to the RM-ANOVA, an effect size for each measure will be calculated based on the same time-frame comparisons. SPSS will be used to process data.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Be-Balanced	The BE-BALANCED program will run for 12-weeks, with participants attending group-based virtual supervised exercise sessions twice weekly. Participants will complete an individual in-person assessment at baseline and again at end of intervention to collect physical outcome measures and will complete questionnaires electronically using REDCap, (or mailed version). Follow-up assessments will be administered electronically to each participant using REDCap at 3-months after program completion (24 weeks post-baseline).

Timeline

• Start date: 2021-06-15
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2021-06-02
• Last updated: 2021-06-02

Locations

1 site across 1 country: Canada