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NCT Number: NCT04575402

Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients

Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

Physical function is a known predictor of QOL in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with Androgen Deprivation Therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prostate cancer patients receiving ADT (+/- radiation) or planning to receive ADT. Start date of ADT must be planned for no more 7 days after baseline, or patients must have started ADT within 6 months prior to enrollment.
  • 18 years or older
  • Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
  • Access to a device that has the capability to sync to the Fitbit
  • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
  • English or Spanish speaking
  • Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

Treatment and study plan

Wearable Activity Monitor

Other

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)

Other names: Fitbit Charge HR, Wearable tracker, Wearable biosensor

Primary outcomes

  1. Physical function decline within 3 months from baseline

    Time frame: 3 months

    Patient-reported physical function defined as 5-point change in standardized NIH PROMIS t-scores (mean 50, SD: 10), where higher scores represent higher physical function)

  2. Absolute change in average step counts at 3 months from baseline

    Time frame: 3 months

    Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit as measured using a Fitbit activity monitor where mean weekly Fitbit activity values will be calculated

Secondary outcomes

  1. Mean change in Fitbit 24-hour activity

    Time frame: 3 months

    Change will be calculated based on difference in 24 hour activity as defined as periods of active minutes, sedentary time, and sleep at baseline and end-of-study

  2. Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity, as assessed in qualitative interviews.

    Time frame: 3 months

    This is a qualitative endpoint assessed in individual patient interviews at end of study.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors

Acronym: DigiPRO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2020
Registry last updated
Aug 27, 2024

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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