NEXT (Nutrition and EXercise During Adjuvant Treatment) Study
NExT
Nutrition and Exercise During Adjuvant Treatment (NEXT) Study Implementation of a Physician-referred Exercise and Healthy Eating Intervention as Supportive Care in Breast Cancer Survivors
1 other identifier
interventional
73
1 country
2
Brief Summary
This study will offer a supervised exercise program and healthy eating education to women with breast cancer undergoing chemotherapy as a physician-referred program and measure the adoption, adherence and satisfaction with the intervention as well as its health effects. Past trials have demonstrated various health benefits of exercise yet it is not currently part of supportive care and few suitable programs exist in the community or outside of research. This study is expected to address the unique barriers related to exercise in breast cancer survivors and to better understand how the intervention might work in a real life setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Aug 2013
Typical duration for not_applicable breast-cancer
2 active sites
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
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2016
CompletedApril 24, 2017
April 1, 2017
2.4 years
February 27, 2013
April 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals
2 years
Secondary Outcomes (1)
Means and standard deviations
2 years
Other Outcomes (1)
Healthcare Utilization costs
2 years
Study Arms (1)
Cancer Treatment
OTHERInterventions
Eligibility Criteria
You may qualify if:
- female;
- aged 19 years and older;
- newly diagnosed with early stage (I-IIIA) breast cancer;
- prescribed adjuvant chemotherapy (with or without radiation) as part of curative treatment for breast cancer; and
- good comprehension of English
You may not qualify if:
- contraindications for entry into an exercise program (i.e., known cardiovascular disease, uncontrolled diabetes mellitus, or musculoskeletal impairment issue);
- body mass index (BMI) \>40 (morbid obesity);
- mobility impairment requiring use of mobility aids;
- stage IV cancer
- metastatic disease
- neo-adjuvant chemotherapy (with likelihood of surgery after chemotherapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- British Columbia Cancer Agencycollaborator
Study Sites (2)
Breast Cancer Training Center
Vancouver, British Columbia, V5Z 4C2, Canada
Fitness Centre
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Campbell, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kristin Campbell
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 7, 2013
Study Start
August 6, 2013
Primary Completion
January 13, 2016
Study Completion
December 3, 2016
Last Updated
April 24, 2017
Record last verified: 2017-04