Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
NCT ID: NCT02969577
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2017-03-07
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
Usual Care with Attention (UCA)
Participants will receive the usual care they would normally receive if not taking part in this study.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
MALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sally Maliski, PhD, RN, FAAN
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00004205
Identifier Type: -
Identifier Source: org_study_id
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