An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
Study Overview
Brief Summary
The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Detailed Description
The primary objective of this study is to test a theory-based, micro-randomized trial to determine the optimal state to deliver a message to increase physical activity by determining the probability older cancer survivors will be physically active in the one hour following a messaging prompt. The secondary, exploratory objective is to determine the probability older cancer survivors will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Eligibility criteria is deliberately incomplete to preserve the scientific integrity of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 65 years.
- •Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.
- •Fluent in spoken and written English.
- •Patient has access to smartphone
- •Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- •Patient has metastatic disease.
- •Patient has cancer recurrence.
Arms & Interventions
Micro-randomized trial study arm
In this one-armed, 4-week trial, participants will receive prompts to report their pain symptoms 4 times throughout the day. Participants may receive up to 4 reminders to move messages throughout the day to promote participants to engage in physical activity. The receipt of messages is randomized each day. Participants will wear a research-grade activity monitor throughout the duration of their participation in the intervention to measure physical activity behaviors.
Intervention: Physical Activity Promotion Intervention (Behavioral)
Outcomes
Primary Outcomes
ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
Time Frame: 4 weeks
Physical activity will be measured using an ActiGraph accelerometer. Data will be aggregated into physical activity estimations (sedentary, light, moderate, vigorous, steps, etc.) using standard methods. Outcome of interest will be probability older cancer survivors are physically active in the 30 minutes following the receipt of a messaging prompt to promote physical activity.
11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time Frame: 4 weeks
Pain state will be assessed by response to the pain rating measured by the 11-Point Box Scale in the study app. Participants will receive a smart phone prompt to rate their pain 4 times per day. Outcome of interest will be probability older cancer survivors experience a pain episode in the 24 hours following the receipt of a messaging prompt to increase physical activity.
Secondary Outcomes
No secondary outcomes reported
Investigators
Whitney Morelli
PhD, Assistant Professor
Medical College of Wisconsin