Be-Active Study - Increasing Physical Activity in Cancer Survivors

NCT05376293 | Completed Results

• 1 other identifier: 1850077
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Exercise; Cancer Survivors

Outcome Measures

Primary Outcomes (4)

• Change in Physical Activity

  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

  baseline to 3 months

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

  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.

  weekly from weeks 2-12

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

  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.

  weekly during weeks 1-12

• Program Satisfaction Via Likert Scale

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

  3 months

Secondary Outcomes (4)

• 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 Arms (2)

Behavioral internet program

ACTIVE COMPARATOR

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

Informational newsletter condition

SHAM COMPARATOR

Participants randomized to the newsletter condition will receive 6 newsletters, delivered every other week during the 3-month program.

Behavioral: Informational newsletter condition

Interventions

Behavioral Internet program BEHAVIORAL

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.

Behavioral internet program

Informational newsletter condition BEHAVIORAL

Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.

Informational newsletter condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any medical condition for which physical activity is contraindicated
• Unable to attend assessment visits in Providence RI

Sponsors & Collaborators

• The Miriam Hospital: lead
• Brown University: collaborator

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Jessica Unick
• Organization: The Miriam Hospital

junick@brownhealth.org

401-793-7966

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 17, 2022
• Study Start: August 23, 2022
• Primary Completion: December 4, 2023
• Study Completion: April 6, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-01

Locations

US (1)