Clinical trial NCT05376293: Be-Active Study - Increasing Physical Activity in Cancer Survivors
Official title: Web-based Intervention for Increasing Physical Activity in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Exercise
Cancer Survivors
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2022-05-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Physical Activity
timeFrame: baseline to 3 months
measure: Intervention Engagement - Planning of Physical Activity (Internet Program Only)
timeFrame: weekly from weeks 2-12
measure: Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)
timeFrame: weekly during weeks 1-12
measure: Program Satisfaction Via Likert Scale
timeFrame: 3 months
Secondary outcomes:
measure: Fatigue Measured Via the Brief Fatigue Inventory (BFI)
timeFrame: baseline to 3 months
measure: Health-related Quality of Life (General Health Subscale) Measured Via the SF-36
timeFrame: baseline to 3 months
measure: Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)
timeFrame: baseline to 3 months
measure: Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: