Cancer Survivors, Exercise, Physical Activity
Conditions
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
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.
Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Program Satisfaction Via Likert Scale | 3 months | Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received? (higher score indicates greater satisfaction) |
| Change in Physical Activity | baseline to 3 months | 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 |
| Intervention Engagement - Planning of Physical Activity (Internet Program Only) | weekly from weeks 2-12 | 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. |
| Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only) | weekly during weeks 1-12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Measured Via the Brief Fatigue Inventory (BFI) | baseline to 3 months | 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). |
| Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 | baseline to 3 months | 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). |
| Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18) | baseline to 3 months | 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. |
| Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) | baseline to 3 months | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 46 |
Baseline characteristics
| Characteristic | Informational Newsletter Condition | Total | Behavioral Internet Program |
|---|---|---|---|
| Age, Continuous | 56.0 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 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 41 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 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 | 18 Participants | 38 Participants | 20 Participants |
| Sex: Female, Male Female | 23 Participants | 42 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Change in Physical Activity | 49.3 minutes per week | Standard Deviation 90.5 |
| Informational Newsletter Condition | Change in Physical Activity | 15.1 minutes per week | Standard Deviation 100.4 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Intervention Engagement - Planning of Physical Activity (Internet Program Only) | 82.6 percentage of weeks | Standard Deviation 25.8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only) | 85.9 percentage of weeks | Standard Deviation 22.1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Program Satisfaction Via Likert Scale | 5.81 units on a scale | Standard Deviation 1.6 |
| Informational Newsletter Condition | Program Satisfaction Via Likert Scale | 3.23 units on a scale | Standard Deviation 1.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Fatigue Measured Via the Brief Fatigue Inventory (BFI) | -0.32 units on a scale | Standard Deviation 1.93 |
| Informational Newsletter Condition | Fatigue Measured Via the Brief Fatigue Inventory (BFI) | -0.38 units on a scale | Standard Deviation 1.91 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) | -1.67 units on a scale | Standard Deviation 4.55 |
| Informational Newsletter Condition | Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) | -1.41 units on a scale | Standard Deviation 4.33 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 | 2.05 units on a scale | Standard Deviation 10.54 |
| Informational Newsletter Condition | Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 | 3.64 units on a scale | Standard Deviation 11.57 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Internet Program | 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 |
| Informational Newsletter Condition | Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18) | 0.5 units on a scale | Standard Deviation 5.18 |