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

This study has been completed.
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01806181
First received: February 27, 2013
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
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 Intervention
Breast Cancer
Other: Exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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).


Enrollment: 73
Actual Study Start Date: August 6, 2013
Study Completion Date: December 3, 2016
Primary Completion Date: January 13, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cancer Treatment Other: Exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806181

Locations
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
Investigators
Principal Investigator: Kristin Campbell, PhD University of British Columbia
  More Information

Additional Information:
Responsible Party: Kristin Campbell, University of British Columbia
ClinicalTrials.gov Identifier: NCT01806181     History of Changes
Other Study ID Numbers: H12-02504
Study First Received: February 27, 2013
Last Updated: April 20, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2017