Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05176756 |
| Other study ID # |
UPCC 21921 |
| Secondary ID |
849679 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 14, 2022 |
| Est. completion date |
March 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Abramson Cancer Center at Penn Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a two-arm, randomized, controlled trial to evaluate the effectiveness of using a
behaviorally designed gamification intervention with social support compared to an attention
control group to increase physical activity during a 6-month intervention with a 3-month
follow-up period. We will enroll 150 Black or Hispanic breast and prostate cancer survivors
who are at an especially high risk for developing major CVD from two U.S. cancer centers: the
University of Pennsylvania Health System and City of Hope National Medical Center. All
participants will receive a wearable activity tracker (Fitbit) and will be enrolled in the
Way to Health system, a research information technology platform at the University of
Pennsylvania. Within the Way to Health platform, patients will set a goal to increase daily
step count from baseline, and will then be randomized to gamification plus social support or
to attention control. The study will evaluate the effect of the gamification intervention on
daily physical activity (as measured by daily steps and moderate to vigorous physical
activity), physical function, fatigue, and health-related quality of life.
Description:
The specific objectives of this study are the following:
1. To determine the effectiveness of a behaviorally designed gamification intervention with
social support to increase physical activity in Black and Hispanic breast and prostate
cancer survivors
2. To evaluate the effects of the gamification intervention on physical function, fatigue,
and health-related quality of life
Recruitment: Participants will be recruited from the tumor registries at the two cancer
centers or via direct referral from these two health systems. Patients identified from tumor
registries will be emailed a link to the study, after obtaining provider permission to
contact. Patients will then be contacted by phone two weeks later to further discuss the
study. Interested patients will visit the study website on the Way to Health platform to
learn more about the study, create an account, provide informed consent, and complete initial
baseline eligibility surveys. Study coordinators will be available to assist patients with
this process, as necessary.
Informed Consent: We will follow an IRB-approved approach taken by many studies using the Way
to Health platform to obtaining informed consent. Upon reaching the portal, potential
participants will be asked to create an account and will then be informed of the details of
the study, including its objectives, duration, requirements, and financial payments. The Way
to Health portal will then take interested participants through an online informed consent.
Successive screens will explain the voluntary nature of the study, the risks and benefits of
participation, alternatives to participation, and that participants can withdraw from the
study at any time. On the final consent screen, potential participants who click a clearly
delineated button stating that they agree to participate in the study will be considered to
have consented to enroll. Participants will be provided with details regarding how to contact
the research team via email or phone at any time if they subsequently wish to withdraw from
the study. Support partners will provide verbal informed consent via telephone for their
name, email address, and phone number to be stored in the study database. For participants
who are English-speaking but illiterate, an authorized family member will be present to
witness the oral presentation of the consent form and both participant and authorized family
member sign the consent form. Spanish speaking patients will be consented with the aid of a
medical interpreter. Directly referred patients will also complete informed consent via the
Way to Health platform as above.
Enrollment: Immediately after completing the informed consent process, potentially eligible
patients will be prescreened to ensure they meet the eligibility criteria. Simultaneously,
participants will complete an online questionnaire to confirm eligibility and complete the
study surveys.
Study surveys: The baseline questionnaire will include demographics, as well as validated
surveys on health status, exercise self-efficacy, other forms of exercise besides step counts
(e.g. swimming, biking), and health-related quality of life (EQ-5D-5L). To assess physical
function and fatigue, they will complete the Patient Reported Outcome Measure Information
System (PROMIS) Physical Function, Global-10 scales, 6b, and Cancer Fatigue Short Form
scales. We will also assess the social determinants of health (SDOH) through a validated,
reliable and reproducible instrument focused on the core, structural, and individual SDOH.
Determination of Baseline Step Count and Goal-Setting: After completing the baseline
questionnaire, eligible participants will be mailed a wearable activity tracking device and
asked to get used to the wearable device for a few weeks. During this run-in period, baseline
activity measures (daily step counts, minutes of moderate-to-vigorous physical activity,
minutes of sleep) will be estimated. If fewer than 4 days of data are available during the
second week, study coordinators will reach out to the participant to inquire about any device
issues and the run-in period will be extended until at least 4 days of data are captured.
Participants who do not complete this run-in phase will not be randomized into the trial, nor
will patients with step counts > 7500 steps/day during the run-in phase. Once baseline
measures have been established, eligible participants will be contacted to choose a goal step
goal increase between 1500 to 3000 steps above their baseline. Participants will be able to
adjust their step goal at any time during the study, as long as it is within this range.
Randomization: Participants that have established baseline measures and finished goal
selection will be randomly assigned to control or the intervention using a 1:1 allocation,
stratifying by site (Penn or City of Hope) and on baseline step count (<4000, 4000-5999,
6000-7500), and block sizes of 2 using an electronic number generator through the Way to
Health platform.
End-of-study: At the end of the 6-month intervention and 3-month follow-up period, patients
will be alerted by the Way to Health platform to return to the study website to complete an
end-of-study questionnaire consisting of the EQ-5D-5L, PROMIS Physical Function and Global-10
scales, the PROMIS Cancer Fatigue Short Form, and the Godin Leisure Time exercise
questionnaire.
Subject compensation: To reduce dropout and the risk of differential attrition by arm, all
participants will receive $25 for enrolling in the study, $25 for completing 6-months, and
$50 for completing 9 months (total of $100).
Data analyses: Data for all consented patients, whether or not they completed all protocol
requirements, will be included for analysis. All analyses will be performed by faculty and
staff statisticians at the University of Pennsylvania using intention-to-treat and will be
adjusted for the stratification factors used at randomization. A two-sided Type I error=0.05
will be used.
