Recruiting

Motivational Intervention

Sponsor:

Stony Brook University

Code:

NCT07215091

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Brief Motivational Intervention

Study Details

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

Study ID

NCT07215091

Start date

Jan 4, 2025

Status verified date

Oct, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

Primary outcome measure

  • Change in Moderate to Vigorous Physical Activity [ Time Frame: Baseline to end of study (6 months) ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

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

Contacts

Principal Investigator:

Pamela K Ginex, EdD, MPH, RN

More Information

Sponsor

Stony Brook University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • World Trade Center Health Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-10-14.