NEXT (Nutrition and EXercise During Adjuvant Treatment) Study (NExT)
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.
Focus of the Study is to Measure Health Effects of Exercise and Healthy Eating Information When Provided as Part of Supportive Care During Cancer Treatment.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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|
- The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Means and standard deviations [ Time Frame: 2 years ] [ Designated as safety issue: No ]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
- Healthcare Utilization costs [ Time Frame: 2 years ] [ Designated as safety issue: No ]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).
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Canada, British Columbia|
|Breast Cancer Training Center||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 4C2|
|Contact: Lisa Currer email@example.com|
|Principal Investigator: Cheri Van Patten|
|Not yet recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Cheri Van Patten 604-877-6000 ext 673271|
|Contact: Kristin Campbell, PhD 604-827-4704|