Be-Active Study - Increasing Physical Activity in Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Web-based Intervention for Increasing Physical Activity in Cancer Survivors

Conditions
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Physical Activity, Exercise, Cancer Survivors

Intervention / Treatment
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* Behavioral: Behavioral Internet program
* Behavioral: Informational newsletter condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral internet program<br>Participants randomized to the Internet program will receive a 12-week behavioral Internet program designed to increase physical activity to recommended levels. | Behavioral: Behavioral Internet program<br>* 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.<br>|
| Sham Comparator: Informational newsletter condition<br>Participants randomized to the newsletter condition will receive 6 newsletters, delivered every other week during the 3-month program. | Behavioral: Informational newsletter condition<br>* Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity as assessed by Actigraph accelerometers | minutes/week of moderate-to-vigorous intensity physical activity | 3 months | 
| Intervention engagement - self-monitoring of physical activity (Internet program only) | number of days that exercise minutes were reported on the study website | 3 months | 
| Program satisfaction via Likert scale | Participants use a 1-7 Likert scale to answer 'how satisfied are you with the program received? (higher score indicates greater satisfaction) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in weight will be assessed using weight at baseline and 3 months | 3 months | 
| Fatigue measured via the Brief Fatigue Inventory (BFI) | Change from baseline to 3 months will be assessed (BFI scores range from 0-10 with higher scores indicating greater fatigue) | 3 months | 
| Health-related quality of life measured via the SF-36 | Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life) | 3 months | 
| Sleep measured via the Pittsburgh Sleep Quality Index (PSQI) | Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality) | 3 months | 
| Anxiety/depression measured via the Brief Symptom Inventory-18 (BSI-18) | Change from baseline to 3 months will be assessed (BSI-18 scores range from 0-72 with higher scores indicating greater depression and anxiety severity) | 3 months | 
| Fear of recurrence measured via the Fear of Cancer Recurrence Inventory (FCRI) | Change from baseline to 3 months will be assessed (FCRI scores range from 0-36 with greater scores indicating greater fear of recurrence) | 3 months |