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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Behavioral: Be-Balanced

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Mackenzie; Phone Number: 2508972609; Email: kelly.mackenzie@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • Clinical Exercise Physiology Lab
      • Contact: Kelly P Lab; Phone Number: 12508972609; Email: kelly.mackenzie@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; This is a single arm pilot study of group base exercise

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual	Assessed by meeting accrual targets (number recruited)	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.	Baseline to 12 weeks
Attrition	Assessed as number of drop-outs during the 12-week program.	Baseline to 12 weeks
Fidelity of group belonging	Group Belonging Scale (0-20; higher is better)	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function: Gait speed	Measured by the gait speed portion of The Short Physical Performance Battery. Measured in seconds.	Change from baseline to 12 weeks (end of intervention)
Physical function: Functional mobility	Measured by 8 foot timed up and go (Seniors Fitness Test). Measured by distance in seconds.	Change from baseline to 12 weeks (end of intervention)
Physical function: Lower extremity strength and endurance	Measured by 30-second chair stand (Seniors Fitness Test). Measured in repetitions completed.	Change from baseline to 12 weeks (end of intervention)
Physical function: Upper extremity strength and endurance	Measured by 30-second biceps curl (Seniors Fitness Test). Measured in repetitions completed.	Change from baseline to 12 weeks (end of intervention)
Physical function: Balance	Measured by Functional Reach Test. Measured in centimeters.	Change from baseline to 12 weeks (end of intervention)
Cardiovascular Fitness	Measured by the Six Minute Walk test. Measured in meters.	Change from baseline to 12 weeks (end of intervention)
Height	Measured using stadiometer. Measured in meters	Change from baseline to 12 weeks (end of intervention)
Weight	Measured using a scale. Measured in kilograms	Change from baseline to 12 weeks (end of intervention)
Body mass index	Aggregated measure of height and weight, reported in kilograms/meter^2	Change from baseline to 12 weeks (end of intervention)
Waist circumference	Measured in centimeters	Change from baseline to 12 weeks (end of intervention)
Hip circumference	Measured in centimeters	Change from baseline to 12 weeks (end of intervention)
Health-related quality of life: Physical Health	Measured by 36-item Short Form Health Survey; Norm-based 0-100, higher score represents better health	Change from baseline to 12 weeks (end of intervention)
Health-related quality of life: Mental Health	Measured by 36-item Short Form Health Survey; Norm-based 0-100, higher score represents better health	Change from baseline to 12 weeks (end of intervention)
Depression and anxiety	Measured by Hospital Anxiety and Depression Scale; Score range 0-21, higher score is higher depression and anxiety.	Change from baseline to 12 weeks (end of intervention)
Usual physical activity levels	Measured by Modified Godin Leisure Time Physical Activity questionnaire; Scoring range 0 - no specified maximum. Scoring < 14 units "insufficiently Active" ; 14-23 is "moderately active" and >=24 is "active".	Change from baseline to 12 weeks (end of intervention)
Falls	Measured by standard falls calendar for the duration of the study as number of falls.	Change from baseline to 12 weeks (end of intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate patient satisfaction	Overall satisfaction; measured on scale 0-7 with higher score meaning higher satisfaction.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: British Columbia Cancer Agency
• Investigators: Principal Investigator: Kristin L Campbell, Department of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Virtual; Healthy Eating; Supervised Exercise
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: H20-02654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No