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Trial record 1 of 1 for:    URCC 08106
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Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (EXCAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924651
First Posted: June 19, 2009
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
Results First Submitted: February 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Intervention: Behavioral: exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Care + EXCAP

Personalized exercise prescription

exercise: home based walking and progressive resistance training exercise

Standard Care Wait list control

Participant Flow:   Overall Study
    Standard Care + EXCAP   Standard Care
STARTED   356   337 
COMPLETED   331   312 
NOT COMPLETED   25   25 
Chemo started too soon                2                3 
No Reason                3                7 
Overwhelmed                6                6 
Noncompliant                1                4 
Medical                1                3 
Changed Mind                10                1 
Incomplete Form                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Care + EXCAP

Personalized exercise prescription

exercise: home based walking and progressive resistance training exercise

Standard Care Wait list control
Total Total of all reporting groups

Baseline Measures
   Standard Care + EXCAP   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 331   312   643 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (11.9)   56.4  (10.1)   56.8  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      306  92.4%      298  95.5%      604  93.9% 
Male      25   7.6%      14   4.5%      39   6.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity, Customized       
White      285  86.1%      265  84.9%      550  85.5% 
Black      30   9.1%      30   9.6%      60   9.3% 
Other      16   4.8%      17   5.4%      33   5.1% 
Body Mass Index (BMI) [1] 
[Units: Kg / m^2]
Mean (Standard Deviation)
 30.1  (6.7)   30.2  (6.4)   30.1  (6.5) 
[1] Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese".
Currently Employed 
[Units: Participants]
Count of Participants
     
Employed outside the house      184  55.6%      184  59.0%      368  57.2% 
Self-Employed      11   3.3%      16   5.1%      27   4.2% 
Home-Maker with >= 1 dependents      32   9.7%      23   7.4%      55   8.6% 
Unemployed      104  31.4%      89  28.5%      193  30.0% 
Marital Status 
[Units: Participants]
Count of Participants
     
Married or long-term committed relationship      236  71.3%      214  68.6%      450  70.0% 
Divorced or separated      24   7.3%      40  12.8%      64  10.0% 
Single      44  13.3%      36  11.5%      80  12.4% 
Widowed      27   8.2%      22   7.1%      49   7.6% 
Education 
[Units: Participants]
Count of Participants
     
Graduate degree      67  20.2%      46  14.7%      113  17.6% 
2 or 4 degree or Some college      165  49.8%      165  52.9%      330  51.3% 
High school / GED degree      88  26.6%      86  27.6%      174  27.1% 
No high school or GED degree      10   3.0%      14   4.5%      24   3.7% 
Unknown      1   0.3%      1   0.3%      2   0.3% 
Cancer Type 
[Units: Participants]
Count of Participants
     
Breast      271  81.9%      267  85.6%      538  83.7% 
Lymphoma      17   5.1%      7   2.2%      24   3.7% 
Colon      20   6.0%      15   4.8%      35   5.4% 
Lung      6   1.8%      9   2.9%      15   2.3% 
Other      17   5.1%      14   4.5%      31   4.8% 
Cancer Stage [1] 
[Units: Participants]
Count of Participants
     
Stage I      80  24.2%      84  26.9%      164  25.5% 
Stage II      150  45.3%      139  44.6%      289  44.9% 
Stage III      84  25.4%      77  24.7%      161  25.0% 
Stage IV      6   1.8%      5   1.6%      11   1.7% 
Unknown      11   3.3%      7   2.2%      18   2.8% 
[1]

Stage I.This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body.

Stage II and III.These stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not other parts of the body.

Stage IV.This stage means that the cancer has spread to other organs or parts of the body. It may also be called metastatic cancer.

Unknown Stage. There is not enough information to determine stage.

Stage I is best, Stage IV is worst.

Previous Treatment - Surgery 
[Units: Participants]
Count of Participants
     
Yes      296  89.4%      275  88.1%      571  88.8% 
No      35  10.6%      37  11.9%      72  11.2% 
Previous Treatment - Chemotherapy 
[Units: Participants]
Count of Participants
     
Yes      2   0.6%      4   1.3%      6   0.9% 
No      329  99.4%      308  98.7%      637  99.1% 
Previous Treatment - Radiation Therapy 
[Units: Participants]
Count of Participants
     
Yes      8   2.4%      6   1.9%      14   2.2% 
No      323  97.6%      306  98.1%      629  97.8% 
Previous Treatment - Hormone Therapy 
[Units: Participants]
Count of Participants
     
Yes      13   3.9%      8   2.6%      21   3.3% 
No      318  96.1%      304  97.4%      622  96.7% 
Time since end of first cancer treatment, weeks 
[Units: Weeks]
Mean (Standard Deviation)
 14.5  (72.9)   6.8  (23.7)   10.8  (55.2) 
Karnofsky Performance Status (KPS) [1] 
[Units: Karnofsky Performance Scale]
Mean (Standard Deviation)
 94.2  (7.1)   94.8  (6.8)   94.5  (7.0) 
[1] Measure Description: The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10.
Exercise Stages of Change 
[Units: Participants]
Count of Participants
     
Not exercising and don't intend to in next 6 month      43  13.0%      36  11.5%      79  12.3% 
Not exercising but do intend to in next 6 months      89  26.9%      83  26.6%      172  26.7% 
Not exercising but intend to in next 30 days      199  60.1%      192  61.5%      391  60.8% 
Exercising and have been for less than 6 months      0   0.0%      1   0.3%      1   0.2% 
Exercising and have been for more than 6 months      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)   [ Time Frame: 41 days: Day 0 (before intervention) Day 41 (post intervention) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Karen M. Mustian, PhD, MPH, Associate Professor
Organization: University of Rochester Medical Center
phone: 585-273-1796
e-mail: Karen_Mustian@urmc.rochester.edu



Responsible Party: Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier: NCT00924651     History of Changes
Other Study ID Numbers: UCCO08106; URCC0701
U10CA037420 ( U.S. NIH Grant/Contract )
UCCO-08106 ( Other Identifier: URCC )
URCC 0701 ( Other Grant/Funding Number: NCI )
First Submitted: June 18, 2009
First Posted: June 19, 2009
Results First Submitted: February 23, 2017
Results First Posted: August 8, 2017
Last Update Posted: August 8, 2017