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

NCT07215091 | Recruiting DMC

• 2 other identifiers: IRB2024-003445R21OH012630-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

World Trade Center Health Program

Outcome Measures

Primary Outcomes (1)

• Change in Moderate to Vigorous Physical Activity

  The primary outcomes will be measured with Fitbit data. Fitbit software allows classification of each minute as being in sedentary, light, moderate, or vigorous activity, and provides metabolic equivalents (METs) for each minute. Positive changes in levels of physical activity will be determined by a 25% increase in MVPA from baseline to end of intervention. This estimation is based on a systematic review of motivational physical activity interventions in cancer survivors (Takemura, 2024). This change in outcome measure is well justified and sensitive to small changes in activity.

  Baseline to end of study (6 months)

Secondary Outcomes (5)

• Quality of Life (SF-20)

  Baseline to end of study (6 months)

• Sleep (PROMIS Sleep SF)

  Baseline to end of study (6 months)

• Fatigue (PROMIS Fatigue SF)

  Baseline to end of study (6 months)

• Physical Functioning (Short Physical Performance Battery)

  Baseline to end of study (6 months)

• Post traumatic stress disorder (PCL-5)

  Baseline to end of study (6 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Brief Motivational Intervention

Wait List Control

ACTIVE COMPARATOR

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.

Behavioral: Brief Motivational Intervention

Interventions

Brief Motivational Intervention 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.

Intervention; Wait List Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-8240, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Pamela K Ginex, EdD. MPH, RN

CONTACT

631 444 6269; pamela.ginex@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: January 4, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)