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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Diet and Nutrition Coaching
Usual Care with Attention
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Androgen deprivation therapy, ADT

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los Angeles
  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Staying Strong & Healthy Intervention (SS&H)

Usual Care with Attention (UCA)

Arm Description

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.

Participants will receive the usual care they would normally receive if not taking part in this study.

Outcomes

Primary Outcome Measures

Change in LDL

Secondary Outcome Measures

Change in Body Mass Index (BMI)
Change in Body Mass Index (BMI)
Change in Lipid Profile
Change in Lipid Profile
Change in Waist/Hip Circumference
Change in Waist/Hip Circumference
Change in Glucose
Change in Glucose
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 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.

Full Information

First Posted
November 17, 2016
Last Updated
February 15, 2021
Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02969577
Brief Title
Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
Official Title
Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Staying Strong & Healthy Intervention + Usual Care 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Androgen deprivation therapy, ADT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Staying Strong & Healthy Intervention (SS&H)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care with Attention (UCA)
Arm Type
Active Comparator
Arm Description
Participants will receive the usual care they would normally receive if not taking part in this study.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet and Nutrition Coaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care with Attention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in LDL
Time Frame
Change from Baseline to Month 12
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Time Frame
Change from Baseline to Month 6
Title
Change in Body Mass Index (BMI)
Time Frame
Change from Baseline to Month 12
Title
Change in Lipid Profile
Time Frame
Change from Baseline to Month 6
Title
Change in Lipid Profile
Time Frame
Change from Baseline to Month 12
Title
Change in Waist/Hip Circumference
Time Frame
Change from Baseline to Month 6
Title
Change in Waist/Hip Circumference
Time Frame
Change from Baseline to Month 12
Title
Change in Glucose
Time Frame
Change from Baseline to Month 6
Title
Change in Glucose
Time Frame
Change from Baseline to Month 12
Title
Change in Health Related Quality
Description
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.
Time Frame
Change from Baseline to Month 6
Title
Change in Health Related Quality
Description
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.
Time Frame
Change from Baseline to Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Maliski, PhD, RN, FAAN
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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