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Recruiting NCT07227077

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

No phase Interventional Breast Cancer Cervical Cancer Bladder Cancer Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Activity Promotion Intervention.
Who it may be relevant to
Registry conditions: Breast Cancer, Cervical Cancer, Bladder Cancer, Colorectal Cancer. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Physical Activity Promotion Intervention
    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 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Froedtert Hospital — Milwaukee

Identifiers

NCT: NCT07227077 · PRO00055140 · K01CA255414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗