The Women In Steady Exercise Research (WISER) Survivor Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01515124
First received: January 18, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lymphedema
Behavioral: Exercise Intervention
Behavioral: Weight Loss Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Clinical lymphedema exacerbation rate [ Time Frame: Baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Quality of life outcomes [ Time Frame: Baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    Quality of life outcomes, including lymphedema related quality of life and body image

  • Biomarkers of breast cancer recurrence [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Biomarkers for mechanistic pathways to link energy balance with recurrence risk.


Estimated Enrollment: 555
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01515124

Contacts
Contact: Kathryn H. Schmitz, MPH, PhD 215-898-6604 schmitz@mail.med.upenn.edu
Contact: Monica J. Laudermilk, PhD 215-746-4929 lamoni@mail.med.upenn.edu

Locations
United States, Pennsylvania
The University of Pennsylvania TREC Survivorship Center/ Perelman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathryn H. Schmitz, MPH, PhD    215-898-6604    schmitz@mail.med.upenn.edu   
Contact: Monica J. Laudermilk, PhD    215-746-4929    lamoni@mail.med.upenn.edu   
Principal Investigator: Kathryn H. Schmitz, MPH, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kathryn H. Schmitz, MPH,PhD University of Pennsylvania
  More Information

Publications:
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin 2009;59(4):225-49.
Hormes JM, Bryan, C., Lytle, L.A., Gross, C.R., Ahmed, R.L., Troxel, A.B., Schmitz, K.H. . Impact of Lymphedema and Arm Symptoms on Quality of Life in Breast Cancer Survivors. Lymphology 2009;In Press.
NLN Medical Advisory Commitee. Position Statement of the National Lymphedema Network. Topic: Lymphedema Risk Reduction Practices. In; 2005:1-2.
Launois R, Mègnigbêto, A.C., Pocquet, K.,Alliot, F. A specific quality of life scale in upper limb lymphedema: the ULL-27 questionnaire. Lymphology 2002;35(Suppl):181-7.

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01515124     History of Changes
Other Study ID Numbers: U54-CA 155850
Study First Received: January 18, 2012
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Lymphedema
Strength training intervention
Weight loss intervention
Breast cancer recurrence
Cost Effectiveness

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014