Clinical trial NCT04911114: Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer
Official title: Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Keywords: Cancer
Supervised Exercise
Virtual
Healthy Eating
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Cancer Agency
First posted: 2021-06-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-arm feasibility study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accrual
timeFrame: Baseline (0 weeks)
measure: Intervention Adherence
timeFrame: Baseline to 12 weeks
measure: Attrition
timeFrame: Baseline to 12 weeks
measure: Fidelity of group belonging
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Physical function: Gait speed
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Physical function: Functional mobility
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Physical function: Lower extremity strength and endurance
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Physical function: Upper extremity strength and endurance
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Physical function: Balance
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Cardiovascular Fitness
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Height
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Weight
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Body mass index
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Waist circumference
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Hip circumference
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Health-related quality of life: Physical Health
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Health-related quality of life: Mental Health
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Depression and anxiety
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Usual physical activity levels
timeFrame: Change from baseline to 12 weeks (end of intervention)
measure: Falls
timeFrame: Change from baseline to 12 weeks (end of intervention)
Other outcomes:
measure: Evaluate patient satisfaction
timeFrame: Baseline to 12 weeks
Locations:
city: Vancouver
country: Canada
facility: Clinical Exercise Physiology Lab
state: British Columbia
Study officials:
affiliation: Department of Physical Therapy
name: Kristin L Campbell
role: PRINCIPAL_INVESTIGATOR
References: