Be-Active Study - Increasing Physical Activity in Cancer Survivors

NCT ID: NCT05376293

Last Updated: 2025-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2024-04-06

Brief Summary

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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

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Conditions

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Physical Activity Exercise Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Behavioral Internet program

Intervention Type 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.

Informational newsletter condition

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

Group Type SHAM_COMPARATOR

Informational newsletter condition

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Informational newsletter condition

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1850077

Identifier Type: -

Identifier Source: org_study_id

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