Prostate CancerNCT02969577
Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
A study testing Exercise Program and Diet and Nutrition Coaching in people with Prostate Cancer, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise Program and Diet and Nutrition Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Exercise Program, Diet and Nutrition Coaching, Usual Care with Attention
- Keywords
- Androgen deprivation therapy, ADT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
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 CoachingBehavioural
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 AttentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Staying Strong & Healthy Intervention (SS&H) | Experimental | 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. Receives: Behavioral: Exercise Program; Behavioral: Diet and Nutrition Coaching; Other: Usual Care with Attention |
| Usual Care with Attention (UCA) | Active comparator | Participants will receive the usual care they would normally receive if not taking part in this study. Receives: Other: Usual Care with Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL
Measured: Change from Baseline to Month 12
Secondary outcomes (10)
Change in Body Mass Index (BMI)
Measured: Change from Baseline to Month 6
Change in Body Mass Index (BMI)
Measured: Change from Baseline to Month 12
Change in Lipid Profile
Measured: Change from Baseline to Month 6
Change in Lipid Profile
Measured: Change from Baseline to Month 12
Change in Waist/Hip Circumference
Measured: Change from Baseline to Month 6
Change in Waist/Hip Circumference
Measured: Change from Baseline to Month 12
Change in Glucose
Measured: Change from Baseline to Month 6
Change in Glucose
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start7 Mar 2017
- Primary completion1 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Sally Maliski, PhD, RN, FAAN, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969577
- Sponsor's protocol ID
- STUDY00004205
- Other IDs
- R01NR014518
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2016
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
- ClinicalTrials.gov ID
- NCT02969577
- Acronym / sponsor ID
- STUDY00004205
- Conditions
- Prostate Cancer
- Keywords
- Androgen deprivation therapy, ADT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staying Strong & Healthy Intervention (SS&H) | Experimental | Behavioral: Exercise Program, Behavioral: Diet and Nutrition Coaching, Other: Usual Care with AttentionParticipants 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. |
| Usual Care with Attention (UCA) | Active comparator | Other: Usual Care with AttentionParticipants will receive the usual care they would normally receive if not taking part in this study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramParticipants 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. | Behavioural | Staying Strong & Healthy Intervention (SS&H) |
| Diet and Nutrition CoachingDiet 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. | Behavioural | Staying Strong & Healthy Intervention (SS&H) |
| Usual Care with AttentionParticipants 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. | Other | Staying Strong & Healthy Intervention (SS&H), Usual Care with Attention (UCA) |
Primary outcome
Change in LDL
Time frame: Change from Baseline to Month 12
10 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Change from Baseline to Month 6
Change in Body Mass Index (BMI)
Time frame: Change from Baseline to Month 12
Change in Lipid Profile
Time frame: Change from Baseline to Month 6
Change in Lipid Profile
Time frame: Change from Baseline to Month 12
Change in Waist/Hip Circumference
Time frame: Change from Baseline to Month 6
Change in Waist/Hip Circumference
Time frame: Change from Baseline to Month 12
Change in Glucose
Time frame: Change from Baseline to Month 6
Change in Glucose
Time frame: Change from Baseline to Month 12
Change in Health Related Quality
Time frame: Change from Baseline to Month 6
Change in Health Related Quality
Time frame: Change from Baseline to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally Maliski, PhD, RN, FAAN principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Diet and Nutrition Coaching in people with Prostate Cancer, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL (time frame: Change from Baseline to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.