Trial Outcomes & Findings for Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy (NCT NCT03000166)
NCT ID: NCT03000166
Last Updated: 2021-08-11
Results Overview
Physical Activity Assessment Inventory (Haas \& Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Completion of post-study measures (average 15 weeks)
Results posted on
2021-08-11
Participant Flow
Of 471 screened participants, 67 met inclusion criteria and were invited to participate in the study. 47 agreed to participate. 25 were randomized to the Step-Up intervention group, and 22 were randomized to the attention control group.
Participant milestones
| Measure |
Step-up Intervention Group
Participants assigned to the intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
|
Overall Study
COMPLETED
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Step-Up Intervention Group
n=25 Participants
Participants assigned to the Step-Up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
n=22 Participants
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.96 years
STANDARD_DEVIATION 4.71 • n=5 Participants
|
32.77 years
STANDARD_DEVIATION 5.79 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fatigue
|
54.2 units on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.6 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
55.3 units on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Light Intensity Physical Activity
|
228.7 minutes/day
STANDARD_DEVIATION 61.3 • n=5 Participants
|
208.7 minutes/day
STANDARD_DEVIATION 60.1 • n=7 Participants
|
220.27 minutes/day
STANDARD_DEVIATION 60.8 • n=5 Participants
|
|
Moderate intensity physical activity
|
13.2 minutes/day
STANDARD_DEVIATION 19.9 • n=5 Participants
|
15.3 minutes/day
STANDARD_DEVIATION 20.0 • n=7 Participants
|
14.1 minutes/day
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Steps/day
|
4227.4 steps/day
STANDARD_DEVIATION 2429 • n=5 Participants
|
4288.8 steps/day
STANDARD_DEVIATION 2545 • n=7 Participants
|
4253.2 steps/day
STANDARD_DEVIATION 2444 • n=5 Participants
|
|
Self-efficacy for Physical Activity
|
62.7 units on a scale
STANDARD_DEVIATION 23.4 • n=5 Participants
|
59.4 units on a scale
STANDARD_DEVIATION 24.4 • n=7 Participants
|
61.2 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Self-regulation for Physical Activity
|
4.24 units on a scale
STANDARD_DEVIATION 1.10 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 0.99 • n=7 Participants
|
4.18 units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of post-study measures (average 15 weeks)Physical Activity Assessment Inventory (Haas \& Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.
Outcome measures
| Measure |
Step-Up Intervention Group
n=25 Participants
Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
n=19 Participants
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
|---|---|---|
|
Self-efficacy for Physical Activity
|
62.6 score on a scale
Standard Deviation 22.9
|
56.2 score on a scale
Standard Deviation 24.4
|
PRIMARY outcome
Timeframe: Completion of post-study measures (average 15 weeks)Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.
Outcome measures
| Measure |
Step-Up Intervention Group
n=25 Participants
Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
n=19 Participants
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
|---|---|---|
|
Self-regulation of Physical Activity
|
4.7 score on a scale
Standard Deviation 0.8
|
4.4 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Completion of post-study measures (average 15 weeks)Measured by accelerometer
Outcome measures
| Measure |
Step-Up Intervention Group
n=16 Participants
Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
n=15 Participants
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
|---|---|---|
|
Steps Per Day
|
4720 steps per day
Standard Deviation 3772
|
3991 steps per day
Standard Deviation 2428
|
SECONDARY outcome
Timeframe: Completion of end-of-study measures (average 15 weeks)Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.
Outcome measures
| Measure |
Step-Up Intervention Group
n=25 Participants
Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
|
Attention Control Group
n=19 Participants
Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
|
|---|---|---|
|
Fatigue Severity
|
53.6 score on a scale
Standard Deviation 7.2
|
57.4 score on a scale
Standard Deviation 8.9
|
Adverse Events
Step-up Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeanne M. Erickson, PhD, RN
University of Wisconsin-Milwaukee
Phone: 414-229-6920
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place