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Be-Active Study - Increasing Physical Activity in Cancer Survivors
NA trial testing Behavioral Internet program in Physical Activity in 46 participants. Completed in 6 April 2024.
| Lead sponsor | The Miriam Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 23 August 2022 |
| Primary completion | 4 December 2023 |
| Estimated completion | 6 April 2024 |
| Sites | 1 location across United States |
The Miriam Hospital
Adults 18 to 70, any sex, with Physical Activity or Exercise. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 49.3 | ± 90.5 |
| Informational Newsletter Condition | 15.1 | ± 100.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 82.6 | ± 25.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 85.9 | ± 22.1 |
Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction)
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 5.81 | ± 1.6 |
| Informational Newsletter Condition | 3.23 | ± 1.6 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | -0.32 | ± 1.93 |
| Informational Newsletter Condition | -0.38 | ± 1.91 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 2.05 | ± 10.54 |
| Informational Newsletter Condition | 3.64 | ± 11.57 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | 0.1 | ± 9.71 |
| Informational Newsletter Condition | 0.5 | ± 5.18 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Internet Program | -1.67 | ± 4.55 |
| Informational Newsletter Condition | -1.41 | ± 4.33 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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