NCT03564171

Brief Summary

To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2018

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4.7 years

First QC Date

March 18, 2018

Last Update Submit

April 11, 2023

Conditions

Breast CancerRehabilitationNeoadjuvant TherapyFeasibility Studies

Outcome Measures

Primary Outcomes (4)

  • Recruitment rate (percent reported by the research analyst )

    What percent of eligible patients were successfuly recruitted in the study

    18 month

  • Exercise compliance rate (percent reported by analysis of data)

    number of exercise sessions per week and mean compliance rate (percent of the prescribed exercises within sessions)

    18 month

  • Attrition rate (percent reported by data analysis)

    what percent of the patients left the study?

    18 month

  • Stress consultation compliance rate (percent reported by data analyst)

    Percent of the patients that have satisfaction with counseling and use of education meterials that are provided to them.

    18 months

Secondary Outcomes (5)

  • Quality of life (FACT-B questionnair)

    18 months

  • Physical activity volume

    6 months

  • Aerobic fitness (6 minute walk test)

    6 months

  • Arm fitness (grip strength test)

    6 months

  • Exercise tolerance ( FACT-An questionnair)

    6 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients will receive standard treatment without added intervention.

Intervention

EXPERIMENTAL

These patients will receive standard treatment plus multimodal intervention (prehabilitation program) including : exercise, nutritional counseling, stress counseling, smoking cessation) before starting chemotherapy.

Combination Product: Prehabilitation

Interventions

PrehabilitationCOMBINATION_PRODUCT

stress counseling, exercise, nutritional counseling, smoking cessation counseling

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older, able to give consent, ECOG 0-1

You may not qualify if:

  • pregnant, \> 80 years, medical contraindications to exercise. History of severe and persistent mental illness, cognitive impairment, recent suicide attempts or \>11 on "Hospital Anxiety and Depression Scale". If very active (\> 24) on the Godin-Shephard scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Frances Wright, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 arms: Intervention and Control (chosen by closed envelope, 1:1 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2018

First Posted

June 20, 2018

Study Start

July 18, 2018

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)