Skip to main content
Clinical Trials/NCT05376293
NCT05376293
Completed
N/A

Web-based Intervention for Increasing Physical Activity in Cancer Survivors

The Miriam Hospital1 site in 1 country46 target enrollmentAugust 23, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Activity
Sponsor
The Miriam Hospital
Enrollment
46
Locations
1
Primary Endpoint
Program Satisfaction Via Likert Scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2022
End Date
April 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Program Satisfaction Via Likert Scale

Time Frame: 3 months

Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction)

Change in Physical Activity

Time Frame: baseline to 3 months

Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity

Intervention Engagement - Planning of Physical Activity (Internet Program Only)

Time Frame: weekly from weeks 2-12

Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.

Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)

Time Frame: weekly during weeks 1-12

Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.

Secondary Outcomes

  • Fatigue Measured Via the Brief Fatigue Inventory (BFI)(baseline to 3 months)
  • Health-related Quality of Life (General Health Subscale) Measured Via the SF-36(baseline to 3 months)
  • Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)(baseline to 3 months)
  • Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)(baseline to 3 months)

Study Sites (1)

Loading locations...

Similar Trials