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Be-Active Study - Increasing Physical Activity in Cancer Survivors

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Lifespan

Status

Completed

Conditions

Physical Activity
Cancer Survivors
Exercise

Treatments

Behavioral: Informational newsletter condition
Behavioral: Behavioral Internet program

Study type

Interventional

Funder types

Other

Identifiers

NCT05376293
1850077

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Behavioral internet program
Active Comparator group
Description:
Participants randomized to the Internet program will receive a 12-week behavioral Internet program designed to increase physical activity to recommended levels.
Treatment:
Behavioral: Behavioral Internet program
Informational newsletter condition
Sham Comparator group
Description:
Participants randomized to the newsletter condition will receive 6 newsletters, delivered every other week during the 3-month program.
Treatment:
Behavioral: Informational newsletter condition

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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