Promoting a Healthier Lifestyle Among Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01419613
First received: August 17, 2011
Last updated: August 20, 2014
Last verified: August 2014

August 17, 2011
August 20, 2014
August 2010
April 2015   (final data collection date for primary outcome measure)
Number of Participants Who Increased Activity After Motivational Interviewing [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: No ]
The primary objective of this study is to evaluate the efficacy of a brief Motivational Interviewing (MI) based intervention, relative to a time and attention control intervention (healthy lifestyle counseling), in promoting physical activity among early-stage breast cancer survivors who are physically inactive but are contemplating increasing their level of physical activity.
Same as current
Complete list of historical versions of study NCT01419613 on ClinicalTrials.gov Archive Site
  • Number of Participants With Desired Impact on Symptoms After Motivational Interviewing [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: Yes ]
    The secondary objectives of this study are (1) to examine the impact of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness; and
  • Number of Participants With Desired Effects From Increased Physical Activity [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: No ]
    (2) to explore whether the degree of change in physical activity acts as a mediator of the expected benefits of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness.
Same as current
Not Provided
Not Provided
 
Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors

The purpose of this study is to find out if a counseling program the investigators have developed can help breast cancer survivors adopt a healthier lifestyle.

Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • Behavioral: Motivational Interviewing
    Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
  • Behavioral: Counseling
    The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
  • Experimental: Motivational Interviewing
    Intervention: Behavioral: Motivational Interviewing
  • Active Comparator: Physical Activity Counseling
    Intervention: Behavioral: Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 18 years of age;
  • be capable of speaking and reading English;
  • be diagnosed with stage 0-II breast cancer;
  • be currently disease free;
  • have been treated surgically for breast cancer;
  • have completed chemotherapy and/or radiotherapy at least three months but no more than two years prior;
  • be physically able to exercise as measured by the Physical Activity Readiness Questionnaire-Revised (Thomas, Reading, & Shephard, 1992) ;
  • be currently physically inactive as measured by the Godin Leisure Time Exercise Questionnaire (Godin & Shepard, 1985); and
  • be contemplating increasing physical activity as measured by the Exercise Stages of Change - Short Form (Marcus, Selby, Niaura, & Rossi, 1992).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01419613
MCC-16265
Yes
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Department of Defense
Principal Investigator: Paul B. Jacobsen, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP