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NCT Number: NCT07227077

Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

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.

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Key information

Conditions

Breast Cancer Behavior Bladder Cancer Breast Diseases Breast Neoplasms Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Kelly Clohesey Clinical Research Coordinator, MOT

CONTACT

[email protected]

414-801-6710

Whitney Morelli, Assistant Professor, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Clohesey Clinical Research Coordinator, MOT

CONTACT

[email protected]

4149554099

Whitney Morelli, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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