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

NCT04911114 | Unknown DMC

• 1 other identifier: H20-02654
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Cancer; Supervised Exercise; Virtual; Healthy Eating

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Physical function: Gait speed

  Change from baseline to 12 weeks (end of intervention)

• Physical function: Functional mobility

  Change from baseline to 12 weeks (end of intervention)

• Physical function: Lower extremity strength and endurance

  Change from baseline to 12 weeks (end of intervention)

• Physical function: Upper extremity strength and endurance

  Change from baseline to 12 weeks (end of intervention)

• Physical function: Balance

  Change from baseline to 12 weeks (end of intervention)

Other Outcomes (1)

• Evaluate patient satisfaction

  Baseline to 12 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

This is a single arm pilot study of group base exercise

Behavioral: Be-Balanced

Interventions

Be-Balanced BEHAVIORAL

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).

Intervention Arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator

Study Sites (1)

Clinical Exercise Physiology Lab

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Kristin L Campbell

  Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Mackenzie

CONTACT

2508972609; kelly.mackenzie@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective single-arm feasibility study

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: June 2, 2021
• Study Start: June 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

CA (1)