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

Medical College of Wisconsin

Status: Enrolling

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

Treatments: Behavioral: Physical Activity Promotion Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07227077

PRO00055140

K01CA255414 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Micro-randomized trial study arm

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Promotion Intervention