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

Clinicaltrials.gov ID: NCT07227077
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 65 Years
b-bullseye-arrow Enrollments 50

Conditions

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

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria:

1. Age greater than or equal to 65 years.
2. Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.
3. Fluent in spoken and written English.
4. Patient has access to smartphone
5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patient has metastatic disease.
2. Patient has cancer recurrence.

Study Plan

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

    Description:

    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.

Outcome Measures

Primary Outcome Measures

ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).

Time Frame: 4 weeks

11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

Time Frame: 4 weeks

Timeline

  • Last Updated
    November 12, 2025
  • Start Date
    November 12, 2025
  • Today
    December 19, 2025
  • Completion Date ( Estimated )
    December 1, 2026

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