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

NCT07227077 | Recruiting DMC

• 2 other identifiers: PRO00055140K01CA255414
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cervical Cancer; Bladder Cancer; Colorectal Cancer; Endometrial Cancer; Lung Cancer; Prostate Cancer

Keywords

Physical Activity; Exercise; Survivorship; Supportive Care; Pain; Symptom Management

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Behavioral: Physical Activity Promotion Intervention

Interventions

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.

Micro-randomized trial study arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient has metastatic disease.
• Patient has cancer recurrence.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Motor Activity; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kelly Clohesey Clinical Research Coordinator, MOT

CONTACT

4149554099; kclohesey@mcw.edu

Whitney Morelli, PhD

CONTACT

wmorelli@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Model Details: Micro-Randomized Trial (MRT)

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)