Trial Outcomes & Findings for Be-Active Study - Increasing Physical Activity in Cancer Survivors (NCT NCT05376293)
NCT ID: NCT05376293
Last Updated: 2025-04-24
Results Overview
Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity
COMPLETED
NA
46 participants
baseline to 3 months
2025-04-24
Participant Flow
Participant milestones
| Measure |
Behavioral Internet Program
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Be-Active Study - Increasing Physical Activity in Cancer Survivors
Baseline characteristics by cohort
| Measure |
Behavioral Internet Program
n=23 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=23 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 7.9 • n=39 Participants
|
56.0 years
STANDARD_DEVIATION 8.8 • n=41 Participants
|
55.2 years
STANDARD_DEVIATION 8.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 monthsChange in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity
Outcome measures
| Measure |
Behavioral Internet Program
n=22 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Change in Physical Activity
|
49.3 minutes per week
Standard Deviation 90.5
|
15.1 minutes per week
Standard Deviation 100.4
|
PRIMARY outcome
Timeframe: weekly from weeks 2-12Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.
Outcome measures
| Measure |
Behavioral Internet Program
n=23 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Intervention Engagement - Planning of Physical Activity (Internet Program Only)
|
82.6 percentage of weeks
Standard Deviation 25.8
|
—
|
PRIMARY outcome
Timeframe: weekly during weeks 1-12Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.
Outcome measures
| Measure |
Behavioral Internet Program
n=23 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)
|
85.9 percentage of weeks
Standard Deviation 22.1
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.
Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction)
Outcome measures
| Measure |
Behavioral Internet Program
n=21 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Program Satisfaction Via Likert Scale
|
5.81 units on a scale
Standard Deviation 1.6
|
3.23 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.
The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue).
Outcome measures
| Measure |
Behavioral Internet Program
n=21 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Fatigue Measured Via the Brief Fatigue Inventory (BFI)
|
-0.32 units on a scale
Standard Deviation 1.93
|
-0.38 units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.
The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health).
Outcome measures
| Measure |
Behavioral Internet Program
n=21 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Health-related Quality of Life (General Health Subscale) Measured Via the SF-36
|
2.05 units on a scale
Standard Deviation 10.54
|
3.64 units on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.
Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety.
Outcome measures
| Measure |
Behavioral Internet Program
n=21 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)
|
0.1 units on a scale
Standard Deviation 9.71
|
0.5 units on a scale
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.
A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence)
Outcome measures
| Measure |
Behavioral Internet Program
n=21 Participants
Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.
|
Informational Newsletter Condition
n=22 Participants
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.
Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.
|
|---|---|---|
|
Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)
|
-1.67 units on a scale
Standard Deviation 4.55
|
-1.41 units on a scale
Standard Deviation 4.33
|
Adverse Events
Behavioral Internet Program
Informational Newsletter Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place