Be-Active Study - Increasing Physical Activity in Cancer Survivors

Not Applicable

Completed

Conditions: Physical Activity
Cancer Survivors
Exercise

Interventions: Behavioral: Behavioral Internet program
Behavioral: Informational newsletter condition

Registration Number: NCT05376293

Lead Sponsor: The Miriam Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Program Satisfaction Via Likert Scale	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	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)	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)	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 Outcome Measures

Name	Time	Method
Fatigue Measured Via the Brief Fatigue Inventory (BFI)	baseline to 3 months	The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue).
Health-related Quality of Life (General Health Subscale) Measured Via the SF-36	baseline to 3 months	The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health).
Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)	baseline to 3 months	Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety.
Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)	baseline to 3 months	A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence)