Testing a Brief Motivational Intervention to Increase Physical Activity for Cancer Survivors

NCT ID: NCT07215091

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-04
• Study Completion Date: 2026-07-01

Brief Summary

The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.

Detailed Description

The World Trade Center Health Program (WTCHP) tracks the ongoing health and well-being of over 91,000 first responders and people who lived and worked near the World Trade Center. Research has established that WTCHP members are at higher risk for a constellation of health conditions, including cancer. Cancer survivors, the focus of this study, are at risk for physical and functional impairment. As WTCHP members with cancer age, developing pragmatic interventions to mitigate physical decline is an important next step in a coordinated program of care and research in this vulnerable population. Physical activity (PA) interventions are strong candidates for investigation, given that physical inactivity in WTCHP members has been correlated with respiratory illness, poor sleep, and PTSD. PA has many health benefits, yet interventions to support PA are not routinely incorporated into clinical practice. Evidence-based guidelines recommend PA counseling in clinical care and health professionals believe they should be doing this. However, a gap remains in implementing PA interventions at the point of care. This study will test an evidence-based motivational intervention to initiate and maintain PA among WTCHP particpatants with cancer.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Motivational Intervention:

The intervention group will receive a 3-component motivational intervention based on the Theory of Planned Behavior in addition to an enhanced standard of care. The components of the intervention include motivational interviewing (MI); mobile health monitoring; and action planning.

At the initial visit, following baseline data collection, the clinician will use MI to build a positive attitude towards physical activity (PA). Next, they will discuss why and how to use Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. Following the in-person baseline visit, participants will be called approximately every 2 weeks during the 3-month intervention period. During these calls, the action plan will be reviewed and updated, and their step count reviewed.

Group Type: EXPERIMENTAL

Brief Motivational Intervention

Intervention Type: BEHAVIORAL

The study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning.

MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research team will develop a PA grid that includes aerobic, strength, and flexibility PA options. The PA grid provides an opportunity to personalize the action plan by choosing from a 'menu' to match interests. Following the in-person baseline visit, participants will be called approximately every 2 weeks (4-5 phone contacts) during the 3-month intervention period to review and update their action plan.

Wait List Control

Wait List Control:

The control group will receive a Fitbit and advice to continue their normal physical activity. At the end of 3 months, the wait-list control group will be seen in the clinic for the motivational intervention which will be the same as the intervention group. They will return to the clinic at the end of the study (6 months) for final data collection. Participants in the wait list control group will use the Fitbit for the full 6 months of the study, during the 3 month waiting period and the 3 month intervention.

Group Type: ACTIVE_COMPARATOR

Brief Motivational Intervention

Intervention Type: BEHAVIORAL

The study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning.

MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research team will develop a PA grid that includes aerobic, strength, and flexibility PA options. The PA grid provides an opportunity to personalize the action plan by choosing from a 'menu' to match interests. Following the in-person baseline visit, participants will be called approximately every 2 weeks (4-5 phone contacts) during the 3-month intervention period to review and update their action plan.

Interventions

Brief Motivational Intervention

The study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning.

MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research team will develop a PA grid that includes aerobic, strength, and flexibility PA options. The PA grid provides an opportunity to personalize the action plan by choosing from a 'menu' to match interests. Following the in-person baseline visit, participants will be called approximately every 2 weeks (4-5 phone contacts) during the 3-month intervention period to review and update their action plan.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participation in the World Trade Center Health Program
• History of cancer, completed treatment
• Ability to be physically active (at minimum be able to walk slowly)

Exclusion Criteria

• Participants receiving active cancer treatment (excluding hormonal therapy);
• Late-stage cancer (metastatic);
• Inability to follow the scheduled visits;
• Women who are pregnant
• Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)
• Inability to speak and read English.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Ginex

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela K Ginex, EdD. MPH, RN

Role: CONTACT

pamela.ginex@stonybrookmedicine.edu

631 444 6269

Facility Contacts

Pamela Ginex, EdD, MPH, RN

Role: primary

pamela.ginex@stonybrookmedicine.edu

631 444 6269

Other Identifiers

5R21OH012630-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2024-00344

Identifier Type: -

Identifier Source: org_study_id