Trial Outcomes & Findings for Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (NCT NCT00924651)
NCT ID: NCT00924651
Last Updated: 2017-08-08
Results Overview
BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
693 participants
Primary outcome timeframe
41 days: Day 0 (before intervention) Day 41 (post intervention)
Results posted on
2017-08-08
Participant Flow
Participant milestones
| Measure |
Standard Care + EXCAP
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
Wait list control
|
|---|---|---|
|
Overall Study
STARTED
|
356
|
337
|
|
Overall Study
COMPLETED
|
331
|
312
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
Reasons for withdrawal
| Measure |
Standard Care + EXCAP
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
Wait list control
|
|---|---|---|
|
Overall Study
Chemo started too soon
|
2
|
3
|
|
Overall Study
No Reason
|
3
|
7
|
|
Overall Study
Overwhelmed
|
6
|
6
|
|
Overall Study
Noncompliant
|
1
|
4
|
|
Overall Study
Medical
|
1
|
3
|
|
Overall Study
Changed Mind
|
10
|
1
|
|
Overall Study
Incomplete Form
|
2
|
1
|
Baseline Characteristics
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
Baseline characteristics by cohort
| Measure |
Standard Care + EXCAP
n=331 Participants
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
n=312 Participants
Wait list control
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
306 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · White
|
285 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Black
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Other
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.1 kg / m^2
STANDARD_DEVIATION 6.7 • n=5 Participants
|
30.2 kg / m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
30.1 kg / m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Currently Employed
Employed outside the house
|
184 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Currently Employed
Self-Employed
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Currently Employed
Home-Maker with >= 1 dependents
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Currently Employed
Unemployed
|
104 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Marital Status
Married or long-term committed relationship
|
236 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Marital Status
Divorced or separated
|
24 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Marital Status
Single
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Education
Graduate degree
|
67 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Education
2 or 4 degree or Some college
|
165 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Education
High school / GED degree
|
88 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Education
No high school or GED degree
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
271 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
538 Participants
n=5 Participants
|
|
Cancer Type
Lymphoma
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Cancer Type
Colon
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Cancer Type
Lung
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cancer Type
Other
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Cancer Stage
Stage I
|
80 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Cancer Stage
Stage II
|
150 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Cancer Stage
Stage III
|
84 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Cancer Stage
Stage IV
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cancer Stage
Unknown
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Previous Treatment - Surgery
Yes
|
296 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
571 Participants
n=5 Participants
|
|
Previous Treatment - Surgery
No
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Previous Treatment - Chemotherapy
Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Previous Treatment - Chemotherapy
No
|
329 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
637 Participants
n=5 Participants
|
|
Previous Treatment - Radiation Therapy
Yes
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Previous Treatment - Radiation Therapy
No
|
323 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
|
Previous Treatment - Hormone Therapy
Yes
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Previous Treatment - Hormone Therapy
No
|
318 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
622 Participants
n=5 Participants
|
|
Time since end of first cancer treatment, weeks
|
14.5 weeks
STANDARD_DEVIATION 72.9 • n=5 Participants
|
6.8 weeks
STANDARD_DEVIATION 23.7 • n=7 Participants
|
10.8 weeks
STANDARD_DEVIATION 55.2 • n=5 Participants
|
|
Karnofsky Performance Status (KPS)
|
94.2 Karnofsky Performance Scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
94.8 Karnofsky Performance Scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
94.5 Karnofsky Performance Scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Exercise Stages of Change
Not exercising and don't intend to in next 6 month
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Exercise Stages of Change
Not exercising but do intend to in next 6 months
|
89 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Exercise Stages of Change
Not exercising but intend to in next 30 days
|
199 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Exercise Stages of Change
Exercising and have been for less than 6 months
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Exercise Stages of Change
Exercising and have been for more than 6 months
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 41 days: Day 0 (before intervention) Day 41 (post intervention)Population: Subjects completing both BFI at day 0 and day 41
BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).
Outcome measures
| Measure |
Standard Care + EXCAP
n=274 Participants
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
n=276 Participants
Wait list control
|
|---|---|---|
|
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)
|
0.9 units on a scale
Standard Deviation 2.4
|
0.7 units on a scale
Standard Deviation 2.3
|
Adverse Events
Standard Care + EXCAP
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Care
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care + EXCAP
n=331 participants at risk
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
n=312 participants at risk
Wait list control
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia, gr 4 leukocytes & neutrophils
|
0.30%
1/331
|
0.00%
0/312
|
|
General disorders
Multi organ failure & susbsequent death
|
0.30%
1/331
|
0.00%
0/312
|
|
Blood and lymphatic system disorders
Neutropenia & possible port infection
|
0.30%
1/331
|
0.00%
0/312
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/331
|
0.32%
1/312
|
|
Blood and lymphatic system disorders
Neutropenia, cough, fever, fatigue
|
0.30%
1/331
|
0.00%
0/312
|
Other adverse events
| Measure |
Standard Care + EXCAP
n=331 participants at risk
Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise
|
Standard Care
n=312 participants at risk
Wait list control
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/331
|
0.32%
1/312
|
|
General disorders
Failure to thrive (dehydra, hypokalemia, anorexia, diarrhea, fatigue
|
0.30%
1/331
|
0.00%
0/312
|
|
Gastrointestinal disorders
Abdominal pain/acute typhilitis w/ neutropenia
|
0.00%
0/331
|
0.32%
1/312
|
|
Vascular disorders
Questionable thrombosis/thrombus/embolism
|
0.30%
1/331
|
0.00%
0/312
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.00%
0/331
|
0.32%
1/312
|
Additional Information
Karen M. Mustian, PhD, MPH, Associate Professor
University of Rochester Medical Center
Phone: 585-273-1796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place