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

University of British Columbia30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Interventions

Be-BalancedBEHAVIORAL

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).

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 50-75 years of age (women tend to be older at time of diagnosis, with a median age in Canada of 62 years); 2. Completed primary chemotherapy treatment (oral maintenance therapy allowed); 3. Are within one year of completion of primary chemotherapy without known recurrence; 4. Have access to a smartphone, tablet, laptop, or desktop computer with a camera and microphone, and a reliable internet connection; 5. Speak English, to ensure safety in delivery of the physical activity intervention Exclusion Criteria: 1. Do not pass pre-exercise screening for safety and do not subsequently provide written medical clearance from their physician to participate; 2. 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); 3. 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

Outcomes

Primary Outcomes

Accrual

Assessed by meeting accrual targets (number recruited)

Time frame: Baseline (0 weeks)

Intervention Adherence

Assessed as number of supervised virtual sessions that a participant attended, out of a total of 24 group exercise sessions, and number of self-directed sessions completed, out of a total of 9 sessions.

Time frame: Baseline to 12 weeks

Attrition

Assessed as number of drop-outs during the 12-week program.

Time frame: Baseline to 12 weeks

Fidelity of group belonging

Group Belonging Scale (0-20; higher is better)

Time frame: Baseline to 12 weeks