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Completed

NCT Number: NCT03761160

Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy

This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits.

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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

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

About this study

This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits. The first phase of the research study seeks to evaluate the experience of the first version of the mobile health app within a group of participants and what they think of it.

The investigators are interested in how individuals react to the use of a developed mobile health app and what they think of it.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Phase 1

  • All recruited participants must have owned a smartphone for >1 year
  • English-speaking.
  • Patients with prostate cancer aged between 40-75 years will be considered.
  • No specific timeframe after prostate cancer diagnosis will be required for these patients.
  • No limitations regarding their disease characteristics will be imposed (e.g. metastatic disease).
  • Patients may or may not be currently receiving treatment Staff members will be recruited from
  • Dana-Farber Cancer Institute Department of Medical Oncology,
  • Brigham and Women's Hospital, Department of Surgery. Staff members aged between 40-75 years old will be considered. Phase 2
  • Men diagnosed with prostate cancer presenting to DF/BWHCC
  • About to initiate ADT for the first time will be considered.
  • Age range 40-75-years
  • The ability to walk 400 m
  • Medical clearance from their primary physician
  • English speaking
  • Cognitively alert
  • Literate
  • Ability to read or hear with or without contacts/glass and hearing aid
  • Ownership of a smartphone for >1yr

Exclusion criteria

  • Men who have been under a rigorous structured exercise regime, such as individuals who engage in more than 900 minutes of moderate physical activity per week in the last 6 months will not be considered
  • Post-ADT treatment
  • Planned systemic chemotherapy
  • Planned treatment with abiraterone or enzalutamide
  • Bone metastases
  • Acute illness
  • Any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put them at risk from exercising
  • Subordinates to the PI

Treatment and study plan

Mobile health app

Other

mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit

Usual Care

Other

Usual care per hospital guidelines

Primary outcomes

  1. Accumulation of body fat mass

    Time frame: 2 years

    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

Secondary outcomes

  1. Whole-body lean mass

    Time frame: 2 years

    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  2. Regional lean mass

    Time frame: 2 years

    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  3. Percent fat

    Time frame: 2 years

    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  4. Estimated visceral adipose

    Time frame: 2 years

    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  5. Application's performance on iOS and Android platforms

    Time frame: 2 years

    This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.

  6. Application's ability to effectively motivate and track outcomes for patients

    Time frame: 2 years

    This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Prostate Cancer Foundation

Registry information

Official study title

Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2018
Registry last updated
Jun 22, 2023

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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