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The Women In Steady Exercise Research (WISER) Survivor Trial

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ClinicalTrials.gov Identifier: NCT01515124
Recruitment Status : Active, not recruiting
First Posted : January 23, 2012
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):

January 18, 2012
January 23, 2012
February 15, 2017
January 2012
September 2017   (Final data collection date for primary outcome measure)
Clinical lymphedema exacerbation rate [ Time Frame: Baseline, 6, and 12 months ]
Lymphedema outcomes include: incident events requiring medical care for lymphedema (e.g. flare-ups or cellulitic infections), arm swelling in the affected limb (Interlimb volume differences), and pain & lymphedema symptoms (number and severity)
Same as current
Complete list of historical versions of study NCT01515124 on ClinicalTrials.gov Archive Site
  • Quality of life outcomes [ Time Frame: Baseline, 6, and 12 months ]
    Quality of life outcomes, including lymphedema related quality of life and body image
  • Biomarkers of breast cancer recurrence [ Time Frame: Baseline and 12 months ]
    Biomarkers for mechanistic pathways to link energy balance with recurrence risk.
Same as current
Not Provided
Not Provided
 
The Women In Steady Exercise Research (WISER) Survivor Trial
The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The purpose of this study is to test the effects of these interventions on lymphedema outcomes, breast cancer recurrence and quality of life.

The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER Survivor interventions and also model the impact of the WISER Survivor interventions over an extended time frame.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Lymphedema
  • Behavioral: Exercise Intervention
    The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.
  • Behavioral: Weight Loss Intervention
    The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.
  • No Intervention: Lymphedema Care Only
  • Experimental: Exercise only
    The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions.
    Intervention: Behavioral: Exercise Intervention
  • Experimental: Weight loss only
    The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact.
    Intervention: Behavioral: Weight Loss Intervention
  • Experimental: Exercise and Weight loss combined
    Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program.
    Interventions:
    • Behavioral: Exercise Intervention
    • Behavioral: Weight Loss Intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
555
September 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • breast cancer survivor
  • overweight or obese (BMI of 25 or greater)
  • must have breast cancer related lymphedema
  • at least 2 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
  • the eligible age range will have no lower or upper limit.
  • currently free of cancer

Exclusion Criteria:

  • medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
  • inability to walk for 6 minutes unaided
  • extremely obese (body mass index greater or equal to 50 kg/m2)
  • plans for additional (e.g. curative or reconstructive) surgery during the study period
  • self-report of weight-lifting within the past year
  • already engaging in 3 or more times weekly aerobic activity of moderate intensity
  • planning to move away from the area over the next year
  • current use of weight loss medication (OTC or prescription)
  • self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
  • weight loss of greater than 10 % in the past 3 months
  • history of bariatric surgery
  • women who are pregnant
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01515124
U54CA155850( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Kathryn H. Schmitz, MPH,PhD University of Pennsylvania
University of Pennsylvania
February 2017

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