Young Adult, Cancer, Physical Activity
Conditions
Brief summary
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.
Detailed description
Interventions to increase physical activity have been shown to relieve fatigue in patients receiving chemotherapy, but no studies have tested a physical activity intervention to improve fatigue in young adults receiving chemotherapy. This study will determine the impact of a physical activity intervention on the self-management process variables of self-efficacy and self-regulation and their relationships to physical activity and fatigue severity in young adults receiving chemotherapy.
Interventions
BEHAVIORALStep-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.
Sponsors
Froedtert Hospital
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
University of Wisconsin, Milwaukee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* have a diagnosis of cancer; * are within the first two months of a chemotherapy regimen that will last at least another 3 months; * are ambulatory without assistance; * have written consent from their physician to participate; * have the ability to understand English; * have access to a computer and the Internet.
Exclusion criteria
* symptoms of uncontrolled cardiopulmonary disease, neurological disease * delayed wound healing * high risk of bone fracture * pre-existing peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Physical Activity | 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. |
| Self-regulation of Physical Activity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps Per Day | Completion of post-study measures (average 15 weeks) | Measured by accelerometer |
| Fatigue Severity | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Step-Up Intervention Group 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. | 25 |
| Attention Control Group Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers. | 22 |
| Total | 47 |
Baseline characteristics
| Characteristic | Step-Up Intervention Group | Total | Attention Control Group |
|---|---|---|---|
| Age, Continuous | 31.96 years STANDARD_DEVIATION 4.71 | 32.3 years STANDARD_DEVIATION 5.2 | 32.77 years STANDARD_DEVIATION 5.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 46 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fatigue | 54.2 units on a scale STANDARD_DEVIATION 10.6 | 55.3 units on a scale STANDARD_DEVIATION 9.4 | 56.6 units on a scale STANDARD_DEVIATION 7.8 |
| Light Intensity Physical Activity | 228.7 minutes/day STANDARD_DEVIATION 61.3 | 220.27 minutes/day STANDARD_DEVIATION 60.8 | 208.7 minutes/day STANDARD_DEVIATION 60.1 |
| Moderate intensity physical activity | 13.2 minutes/day STANDARD_DEVIATION 19.9 | 14.1 minutes/day STANDARD_DEVIATION 19.7 | 15.3 minutes/day STANDARD_DEVIATION 20 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Self-efficacy for Physical Activity | 62.7 units on a scale STANDARD_DEVIATION 23.4 | 61.2 units on a scale STANDARD_DEVIATION 4.2 | 59.4 units on a scale STANDARD_DEVIATION 24.4 |
| Self-regulation for Physical Activity | 4.24 units on a scale STANDARD_DEVIATION 1.1 | 4.18 units on a scale STANDARD_DEVIATION 1.05 | 4.10 units on a scale STANDARD_DEVIATION 0.99 |
| Sex: Female, Male Female | 20 Participants | 25 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 22 Participants | 17 Participants |
| Steps/day | 4227.4 steps/day STANDARD_DEVIATION 2429 | 4253.2 steps/day STANDARD_DEVIATION 2444 | 4288.8 steps/day STANDARD_DEVIATION 2545 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 22 |
| other Total, other adverse events | 0 / 25 | 0 / 22 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 |
Outcome results
Primary
Self-efficacy for Physical Activity
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.
Time frame: Completion of post-study measures (average 15 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Step-Up Intervention Group | Self-efficacy for Physical Activity | 62.6 score on a scale | Standard Deviation 22.9 |
| Attention Control Group | Self-efficacy for Physical Activity | 56.2 score on a scale | Standard Deviation 24.4 |
p-value: 0.22Mixed Models Analysis
Primary
Self-regulation of Physical Activity
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.
Time frame: Completion of post-study measures (average 15 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Step-Up Intervention Group | Self-regulation of Physical Activity | 4.7 score on a scale | Standard Deviation 0.8 |
| Attention Control Group | Self-regulation of Physical Activity | 4.4 score on a scale | Standard Deviation 1.1 |
p-value: 0.4Mixed Models Analysis
Secondary
Fatigue Severity
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.
Time frame: Completion of end-of-study measures (average 15 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Step-Up Intervention Group | Fatigue Severity | 53.6 score on a scale | Standard Deviation 7.2 |
| Attention Control Group | Fatigue Severity | 57.4 score on a scale | Standard Deviation 8.9 |
p-value: 0.2Mixed Models Analysis
Secondary
Steps Per Day
Measured by accelerometer
Time frame: Completion of post-study measures (average 15 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Step-Up Intervention Group | Steps Per Day | 4720 steps per day | Standard Deviation 3772 |
| Attention Control Group | Steps Per Day | 3991 steps per day | Standard Deviation 2428 |
p-value: 0.17Mixed Models Analysis