N/A
N=46
Be-Active Study - Increasing Physical Activity in Cancer Survivors
Physical Activity · Exercise · Cancer Survivors
Bottom Line
View on ClinicalTrials.gov: NCT05376293 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Physical Activity — 49.3; 15.1 minutes per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Internet program (Behavioral); Informational newsletter condition (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Miriam Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity |
49.3; 15.1 | — |
| PRIMARY Intervention Engagement - Planning of Physical Activity (Internet Program Only) |
82.6 | — |
| PRIMARY Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only) |
85.9 | — |
| PRIMARY Program Satisfaction Via Likert Scale |
5.81; 3.23 | — |
| SECONDARY Fatigue Measured Via the Brief Fatigue Inventory (BFI) |
-0.32; -0.38 | — |
| SECONDARY Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 |
2.05; 3.64 | — |
| SECONDARY Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18) |
0.1; 0.5 | — |
| SECONDARY Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) |
-1.67; -1.41 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05376293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.