Working… Menu

NEXT (Nutrition and EXercise During Adjuvant Treatment) Study (NExT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01806181
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : April 24, 2017
British Columbia Cancer Agency
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Exercise Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : August 6, 2013
Actual Primary Completion Date : January 13, 2016
Actual Study Completion Date : December 3, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Cancer Treatment Other: Exercise

Primary Outcome Measures :
  1. The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Means and standard deviations [ Time Frame: 2 years ]
    The secondary outcomes will be will be summarized with means and standard deviations for normally distributed data and assessed by repeated measures ANOVA to examine change over time

Other Outcome Measures:
  1. Healthcare Utilization costs [ Time Frame: 2 years ]
    The exploratory outcomes will be assessed by proportion of participants responses for the patient satisfaction items and healthcare utilization costs will be analyzed by collaborators with the Canadian Centre for Applied Research in Cancer (ARCC).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Gender exclusion criteria: Male breast cancer is excluded as it is a rare diagnosis.

Age exclusion criteria: Based on enrolling adult participants only. Language exclusion criteria: A good comprehension of English is required to receive instruction on the intervention and complete study forms and evaluations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01806181

Layout table for location information
Canada, British Columbia
Breast Cancer Training Center
Vancouver, British Columbia, Canada, V5Z 4C2
Fitness Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Layout table for investigator information
Principal Investigator: Kristin Campbell, PhD University of British Columbia
Additional Information:
Layout table for additonal information
Responsible Party: Kristin Campbell, University of British Columbia Identifier: NCT01806181    
Other Study ID Numbers: H12-02504
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases