Be-Active Study - Increasing Physical Activity in Cancer Survivors

Physical Activity Clinical Trial

Official title:

Web-based Intervention for Increasing Physical Activity in Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05376293
• Other study ID #: 1850077
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: April 6, 2024

Study information

• Verified date: December 2023
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 6, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

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

Related Conditions & MeSH terms

• Cancer Survivors
• Exercise
• Physical Activity

Intervention

Behavioral:
• Behavioral Internet program
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.
• Informational newsletter condition
Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.

Locations

Country	Name	City	State
United States	The Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity as assessed by Actigraph accelerometers	minutes/week of moderate-to-vigorous intensity physical activity	3 months
Primary	Intervention engagement - self-monitoring of physical activity (Internet program only)	number of days that exercise minutes were reported on the study website	3 months
Primary	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	Weight	Change in weight will be assessed using weight at baseline and 3 months	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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