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| ID | Type | Description | Link |
|---|---|---|---|
| K01CA255414 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-randomized trial study arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Promotion Intervention | Behavioral | This physical activity promotion intervention is a micro-randomized trial designed to determine the most effective time to send a message to promote physical activity among cancer survivors who experience chronic pain symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity). | 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. | 4 weeks |
| 11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain). | 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Clohesey Clinical Research Coordinator, MOT | Contact | 4149554099 | kclohesey@mcw.edu | |
| Whitney Morelli, PhD | Contact | wmorelli@mcw.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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Micro-Randomized Trial (MRT)
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D015179 | Colorectal Neoplasms |
| D016889 | Endometrial Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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