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

Ovarian Cancer Clinical Trial

— BE-BALANCED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04911114
• Other study ID #: H20-02654
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: University of British Columbia
• Contact: Kelly Mackenzie
• Phone: 2508972609
• Email: kelly.mackenzie[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Canada	Clinical Exercise Physiology Lab	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate patient satisfaction	Overall satisfaction; measured on scale 0-7 with higher score meaning higher satisfaction.	Baseline to 12 weeks
Primary	Accrual	Assessed by meeting accrual targets (number recruited)	Baseline (0 weeks)
Primary	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
Primary	Attrition	Assessed as number of drop-outs during the 12-week program.	Baseline to 12 weeks
Primary	Fidelity of group belonging	Group Belonging Scale (0-20; higher is better)	Baseline to 12 weeks
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Physical function: Balance	Measured by Functional Reach Test. Measured in centimeters.	Change from baseline to 12 weeks (end of intervention)
Secondary	Cardiovascular Fitness	Measured by the Six Minute Walk test. Measured in meters.	Change from baseline to 12 weeks (end of intervention)
Secondary	Height	Measured using stadiometer. Measured in meters	Change from baseline to 12 weeks (end of intervention)
Secondary	Weight	Measured using a scale. Measured in kilograms	Change from baseline to 12 weeks (end of intervention)
Secondary	Body mass index	Aggregated measure of height and weight, reported in kilograms/meter^2	Change from baseline to 12 weeks (end of intervention)
Secondary	Waist circumference	Measured in centimeters	Change from baseline to 12 weeks (end of intervention)
Secondary	Hip circumference	Measured in centimeters	Change from baseline to 12 weeks (end of intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)