Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Exercise Program; Behavioral: Diet and Nutrition Coaching; Other: Usual Care with Attention

Detailed Description

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

1. Staying Strong & Healthy Intervention + Usual Care
2. Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosed with prostate cancer
• Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
• Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
• Able to speak and read in English or Spanish
• Reachable consistently by telephone
• Able to travel to KUMC

Exclusion Criteria:

• Not diagnosed with prostate cancer
• Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
• Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
• Not able to speak and read in English or Spanish
• Not reachable consistently by telephone
• Not able to travel to the study site for data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staying Strong & Healthy Intervention (SS&H); Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.	Behavioral: Exercise Program; Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.; Behavioral: Diet and Nutrition Coaching; Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.; Other: Usual Care with Attention; Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.
Active Comparator: Usual Care with Attention (UCA); Participants will receive the usual care they would normally receive if not taking part in this study.	Other: Usual Care with Attention; Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LDL	Change from Baseline to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)		Change from Baseline to Month 6
Change in Body Mass Index (BMI)		Change from Baseline to Month 12
Change in Lipid Profile		Change from Baseline to Month 6
Change in Lipid Profile		Change from Baseline to Month 12
Change in Waist/Hip Circumference		Change from Baseline to Month 6
Change in Waist/Hip Circumference		Change from Baseline to Month 12
Change in Glucose		Change from Baseline to Month 6
Change in Glucose		Change from Baseline to Month 12
Change in Health Related Quality	Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.	Change from Baseline to Month 6
Change in Health Related Quality	Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.	Change from Baseline to Month 12

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Sally Maliski, PhD, RN, FAAN, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ADT; Androgen deprivation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STUDY00004205; R01NR014518 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No