Testing a Brief Motivational Intervention to Increase Physical Activity for Cancer Survivors
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorStony Brook University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Participants receiving active cancer treatment (excluding hormonal therapy);
Late-stage cancer (metastatic);
Inability to follow the scheduled visits;
Women who are pregnant
Trial design
Design model
Crossover
Treatments tested in this trial
Brief Motivational Intervention
BehavioralThe 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Wait List ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to end of study (6 months)Secondary outcomes
1
Quality of Life (SF-20)
SF-20 includes 20 quality-of-life statements that are well validated and reliable. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question). The total score will be used to measure quality of life and the physical functioning domain score will be used to subjectively measure physical functioning. Higher scores indicate better health.
Time frame
Baseline to end of study (6 months)2
Sleep (PROMIS Sleep SF)
Sleep will be measured with the PROMIS Sleep Disturbance short form, a 6-item scale that assesses sleep quality and satisfaction with sleep on a five-point Likert scale. The scale is reliable and valid and correlates strongly with longer forms. Higher scores indicate more sleep disturbance.
Time frame
Baseline to end of study (6 months)3
Fatigue (PROMIS Fatigue SF)
Fatigue will be measured with the PROMIS Fatigue short form. This scale includes 8 items related to fatigue and the impact of fatigue on day-to-day life. The form has good reliability (0.88) and validity (.60 -.85) across different groups and has been used across diverse clinical populations. Higher scores indicate more fatigue.
Time frame
Baseline to end of study (6 months)4
Physical Functioning (Short Physical Performance Battery)
Physical function will be derived from performance on the Short Physical Performance Battery (SPPB). The SPPB consists of 3 components: balance (side-by-side, semi-tandem, and tandem positions held for 10 seconds unassisted), gait speed (amount of time to walk a four-meter course at a typical pace), and repetitive chair stand (amount of time to rise from a chair unassisted 5 consecutive times). Each component is rated on a 4-point scale based on the ability and amount of time necessary to complete each task. SPPB ≥10 indicated scores in the normal range, whereas a score of ≤9 indicated functional impairment (further stratified into mild (7-9) vs moderate (4-6) to severe (≤3)). Grip strength will be measured by using a standard dynamometer and assessed from a single 3-s maximal grip effort of the right- and left-side arms. Decreased grip strength has been strongly associated with a range of adverse health outcomes.
Time frame
Baseline to end of study (6 months)Sponsors and contacts
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Source ClinicalTrials.gov