Ovarian CancerBE-BALANCEDNCT04911114
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer
A study testing Be-Balanced in people with Ovarian Cancer, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Be-Balanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Exercise Physiology Lab
Vancouver, British Columbia, V6T 1Z3
Kelly P Lab, 12508972609, kelly.mackenzie@ubc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Be-Balanced
- Keywords
- Cancer, Supervised Exercise, Virtual, Healthy Eating
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be-BalancedBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This is a single arm pilot study of group base exercise Receives: Behavioral: Be-Balanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual
Assessed by meeting accrual targets (number recruited)
Measured: 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.
Measured: Baseline to 12 weeks
Attrition
Assessed as number of drop-outs during the 12-week program.
Measured: Baseline to 12 weeks
Fidelity of group belonging
Group Belonging Scale (0-20; higher is better)
Measured: Baseline to 12 weeks
Secondary outcomes (16)
Physical function: Gait speed
Measured by the gait speed portion of The Short Physical Performance Battery. Measured in seconds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 12 weeks (end of intervention)
Physical function: Balance
Measured by Functional Reach Test. Measured in centimeters.
Measured: Change from baseline to 12 weeks (end of intervention)
Cardiovascular Fitness
Measured by the Six Minute Walk test. Measured in meters.
Measured: Change from baseline to 12 weeks (end of intervention)
Height
Measured using stadiometer. Measured in meters
Measured: Change from baseline to 12 weeks (end of intervention)
Weight
Measured using a scale. Measured in kilograms
Measured: Change from baseline to 12 weeks (end of intervention)
Body mass index
Aggregated measure of height and weight, reported in kilograms/meter^2
Measured: Change from baseline to 12 weeks (end of intervention)
Waist circumference
Measured in centimeters
Measured: Change from baseline to 12 weeks (end of intervention)
Hip circumference
Measured in centimeters
Measured: 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
Measured: 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
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Change from baseline to 12 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Responsible party
- Principal investigator, Kristin Campbell, University of British Columbia
- Investigators
- Kristin L Campbell, Principal investigator, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911114
- Sponsor's protocol ID
- H20-02654
- Acronym
- BE-BALANCED
- Status last verified
- May 2021
- First submitted
- 22 Mar 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)
- ClinicalTrials.gov ID
- NCT04911114
- Acronym / sponsor ID
- BE-BALANCED / H20-02654
- Conditions
- Ovarian Cancer
- Keywords
- Cancer, Supervised Exercise, Virtual, Healthy Eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Be-BalancedThis is a single arm pilot study of group base exercise |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be-BalancedThe 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). | Behavioural | Intervention Arm |
Primary outcome
Accrual
Time frame: Baseline (0 weeks)
Assessed by meeting accrual targets (number recruited)
Intervention Adherence
Time frame: Baseline to 12 weeks
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.
Attrition
Time frame: Baseline to 12 weeks
Assessed as number of drop-outs during the 12-week program.
Fidelity of group belonging
Time frame: Baseline to 12 weeks
Group Belonging Scale (0-20; higher is better)
16 secondary outcomes
Physical function: Gait speed
Time frame: Change from baseline to 12 weeks (end of intervention)
Physical function: Functional mobility
Time frame: Change from baseline to 12 weeks (end of intervention)
Physical function: Lower extremity strength and endurance
Time frame: Change from baseline to 12 weeks (end of intervention)
Physical function: Upper extremity strength and endurance
Time frame: Change from baseline to 12 weeks (end of intervention)
Physical function: Balance
Time frame: Change from baseline to 12 weeks (end of intervention)
Cardiovascular Fitness
Time frame: Change from baseline to 12 weeks (end of intervention)
Height
Time frame: Change from baseline to 12 weeks (end of intervention)
Weight
Time frame: Change from baseline to 12 weeks (end of intervention)
Body mass index
Time frame: Change from baseline to 12 weeks (end of intervention)
Waist circumference
Time frame: Change from baseline to 12 weeks (end of intervention)
Hip circumference
Time frame: Change from baseline to 12 weeks (end of intervention)
Health-related quality of life: Physical Health
Time frame: Change from baseline to 12 weeks (end of intervention)
Health-related quality of life: Mental Health
Time frame: Change from baseline to 12 weeks (end of intervention)
Depression and anxiety
Time frame: Change from baseline to 12 weeks (end of intervention)
Usual physical activity levels
Time frame: Change from baseline to 12 weeks (end of intervention)
Falls
Time frame: Change from baseline to 12 weeks (end of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin L Campbell principal investigator
Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be-Balanced in people with Ovarian Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Mackenzie (2508972609, kelly.mackenzie@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual (time frame: Baseline (0 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.