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

University of British Columbia

Status

Unknown

Conditions

Ovarian Cancer

Treatments

Behavioral: Be-Balanced

Study type

Interventional

Funder types

Other

Identifiers

NCT04911114

H20-02654

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

50-75 years of age (women tend to be older at time of diagnosis, with a median age in Canada of 62 years);
Completed primary chemotherapy treatment (oral maintenance therapy allowed);
Are within one year of completion of primary chemotherapy without known recurrence;
Have access to a smartphone, tablet, laptop, or desktop computer with a camera and microphone, and a reliable internet connection;
Speak English, to ensure safety in delivery of the physical activity intervention

Exclusion criteria

Do not pass pre-exercise screening for safety and do not subsequently provide written medical clearance from their physician to participate;
Do not consent to adhere to safety requirements to participate in a virtual delivery program (i.e., be seen on video for duration of class);
Experienced a fall requiring medical attention in the prior 6 months as individuals may be a higher risk for fall in a virtual physical activity program setting and would be more appropriate for referral to falls clinic