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Be-Active Study - Increasing Physical Activity in Cancer Survivors

Web-based Intervention for Increasing Physical Activity in Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05376293
Enrollment
46
Registered
2022-05-17
Start date
2022-08-23
Completion date
2024-04-06
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivors, Exercise, Physical Activity

Brief summary

Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.

Interventions

BEHAVIORALBehavioral Internet program

The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants will be asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.

BEHAVIORALInformational newsletter condition

Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.

Sponsors

Brown University
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Confirmed cancer diagnosis and have either completed all cancer-directed treatment in the past 3-12 months or be on a maintenance/continuous treatment regimen for which they have been stable for at least 3 months * Inactive - defined as engaging in \<60 min/week of moderate-intensity PA over the past 3 months * BMI between 18.5 and 45 kg/m2 * English speaking * Daily Internet access

Exclusion criteria

* Any medical condition for which physical activity is contraindicated * Unable to attend assessment visits in Providence RI

Design outcomes

Primary

MeasureTime frameDescription
Program Satisfaction Via Likert Scale3 monthsParticipants used a 1-7 Likert scale to answer 'how satisfied are you with the program received? (higher score indicates greater satisfaction)
Change in Physical Activitybaseline 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
Intervention Engagement - Planning of Physical Activity (Internet Program Only)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.
Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)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.

Secondary

MeasureTime frameDescription
Fatigue Measured Via the Brief Fatigue Inventory (BFI)baseline to 3 monthsThe 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).
Health-related Quality of Life (General Health Subscale) Measured Via the SF-36baseline to 3 monthsThe '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).
Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)baseline to 3 monthsPsychological 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.
Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)baseline to 3 monthsA 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
23
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.
23
Total46

Baseline characteristics

CharacteristicInformational Newsletter ConditionTotalBehavioral Internet Program
Age, Continuous56.0 years
STANDARD_DEVIATION 8.8
55.2 years
STANDARD_DEVIATION 8.3
54.4 years
STANDARD_DEVIATION 7.9
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants5 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants41 Participants22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants1 Participants
Race (NIH/OMB)
More than one race
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants38 Participants20 Participants
Sex: Female, Male
Female
23 Participants42 Participants19 Participants
Sex: Female, Male
Male
0 Participants4 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 23
other
Total, other adverse events
0 / 230 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Change in Physical Activity

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

Time frame: baseline to 3 months

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramChange in Physical Activity49.3 minutes per weekStandard Deviation 90.5
Informational Newsletter ConditionChange in Physical Activity15.1 minutes per weekStandard Deviation 100.4
Primary

Intervention Engagement - Planning of Physical Activity (Internet Program Only)

Participants 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.

Time frame: weekly from weeks 2-12

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramIntervention Engagement - Planning of Physical Activity (Internet Program Only)82.6 percentage of weeksStandard Deviation 25.8
Primary

Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)

Participants 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.

Time frame: weekly during weeks 1-12

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramIntervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)85.9 percentage of weeksStandard Deviation 22.1
Primary

Program Satisfaction Via Likert Scale

Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received? (higher score indicates greater satisfaction)

Time frame: 3 months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramProgram Satisfaction Via Likert Scale5.81 units on a scaleStandard Deviation 1.6
Informational Newsletter ConditionProgram Satisfaction Via Likert Scale3.23 units on a scaleStandard Deviation 1.6
Secondary

Fatigue Measured Via the Brief Fatigue Inventory (BFI)

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).

Time frame: baseline to 3 months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramFatigue Measured Via the Brief Fatigue Inventory (BFI)-0.32 units on a scaleStandard Deviation 1.93
Informational Newsletter ConditionFatigue Measured Via the Brief Fatigue Inventory (BFI)-0.38 units on a scaleStandard Deviation 1.91
Secondary

Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)

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)

Time frame: baseline to 3 months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramFear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)-1.67 units on a scaleStandard Deviation 4.55
Informational Newsletter ConditionFear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)-1.41 units on a scaleStandard Deviation 4.33
Secondary

Health-related Quality of Life (General Health Subscale) Measured Via the SF-36

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).

Time frame: baseline to 3 months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramHealth-related Quality of Life (General Health Subscale) Measured Via the SF-362.05 units on a scaleStandard Deviation 10.54
Informational Newsletter ConditionHealth-related Quality of Life (General Health Subscale) Measured Via the SF-363.64 units on a scaleStandard Deviation 11.57
Secondary

Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)

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.

Time frame: baseline to 3 months

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Behavioral Internet ProgramPsychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)0.1 units on a scaleStandard Deviation 9.71
Informational Newsletter ConditionPsychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)0.5 units on a scaleStandard Deviation 5.18

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026