Clinical trial: NCT02168062
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?

Taking part in this study may or may not make your health better. While doctors hope that participation in the STAND clinic or seeing nutrition, exercise, and symptom management services on a referral basis will mitigate the side effects associated with ADT treatment, there is no proof of this. We do know that the information from this study will help doctors learn more about the management of side effects of ADT treatment. This information could help future cancer patients.

Your other choices may include:  
Getting treatment or care for your cancer without being in a study (i.e. hormone therapy).  
Taking part in another study Getting comfort care, also called palliative care - this type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer; comfort care does not treat the cancer directly, it works to improve how you feel and keep you as active and comfortable as possible Getting no treatment
Your physician will discuss these other options with you. Please talk to your doctor about your choices before deciding if you will take part in this study.
Clinical trial: NCT02168062
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The National Cancer Institute (NCI) and other government agencies, e.g., the  
  
Food and Drug Administration (FDA), involved in overseeing research  
The University of California
Participation in research may involve a loss of privacy, but information about you will be handled as confidentially as possible. A medical record will be created because of your participation in this study. Your consent form and some of your research test results will be included in this record. Therefore, your other doctors may become aware of your participation. Hospital regulations require that all health care providers treat information in medical records confidentially.
Clinical trial: NCT02168062
Section: Duration of Study Involvement
Subsections: Before You Begin The Main Part Of The Study...|During The Main Part Of The Study...|All Patients Will Have The Following End Of The Study Visit (12 Months):|Follow Up Visits|How Long Will I Be In The Study?

You will need to have the following exams, tests or procedures to find out if you can be in the main part of the study. Some of these exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. You will also have some procedures that are only being done because you are in the study. These are listed as research procedures. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor. You must complete the following procedures within 6 weeks prior to day 1 of the study. Your visit may take about 1-2 hours.  
Physical exam Review of medical history and assessment of other medical conditions Weight, body mass index. Blood draw (about 2 tablespoons) for PSA, if not already receiving ADT.
Review of medications that you are taking DXA Bone Density Scan: An imaging test that measures bone density (the amount of bone mineral contained in a certain volume of bone) by passing x-rays with two different energy levels through is used to diagnose osteoporosis (decrease in bone mass and density). A bone density scan, using a central machine, takes about 15 minutes, including registration. During the procedure, you will lie on a table scanner for five to eight minutes.  
Measurement of exercise patterns: Your physical activity will be measured using an accelerometer. This is a small plastic device (about 2 inches on each side) that is worn on an elastic waistband around your waist for 7 consecutive days. It must be kept on at all times except when bathing or swimming (it is not waterproof).  
Measurement of the ratio of the length of your 2nd and 4th digit of your right hand Optional CT scan of the radius and tibia (long bones of the arm and leg)

If the exams, tests and procedures show that you can be in the main part of the study,  
  
and you choose to take part, then you will randomized with equal probability to one of the two study "arms" or groups (current standard of care or participation in the STAND clinic). Regardless of your assignment, you will also be placed into one of four strata (subgroups), taking into account the duration of hormone therapy prior to study entry and body mass index at study entry.

You will have an end of treatment visit at approximately 12 months after beginning the study. The visit will take about 2 hours and the following tests and procedures will occur:  
Physical exam Weight, body mass index, and percent body fat measurement Counseling with health care provider to discuss lifestyle modifications, review laboratory results Blood (about 1-2 tablespoons) will be drawn for o Fasting lipid panel/glucose and insulin level o Hemoglobin A1c (to measure glucose levels) o Serum 25-(OH) vitamin D levels o Serum PSA
o Serum testosterone
You will need to fast for at least 10 hours prior to the blood draw.  
Review of medications that you are taking Questions about how your disease is affecting your daily life Quality of life questionnaires  
  
Questions about your nutritional habits Measurement of exercise patterns (accelerometer)
DXA Bone Density Scan Optional CT scan of the radius and tibia (long bones of the arm and leg) Blood (about 1 tablespoon) will be drawn for o To study metabolism changes of your cells o Blood collection for banking

If you are randomized to the group 1 (current standard-of-care study arm), you will have the option to participate in the STAND clinic after the end of study visit at 12 months. Patients who opt to participate in the STAND clinic will be followed for an additional 12 months. The STAND clinic schedule will be identical to that followed by patients initially randomized to the STAND clinic. All patients who have completed the STAND clinic will be followed by telephone calls after 2 and 4 months to see how you are doing. At 6 months following completion of the STAND clinic, you will return for a clinic visit (the visit will take about 1 hour) and have the following procedures:
Physical exam Weight, body mass index, and percent body fat measurement Counseling with health care provider to discuss lifestyle modifications, review laboratory results Blood (about 1-2 tablespoons) for:
o Fasting lipid panel/glucose and insulin level o Hemoglobin A1c o Serum PSA
o Serum testosterone You will need to fast for at least 10 hours prior to the blood draw.  
Quality of life questionnaires Blood (about 1 tablespoon) will be drawn for o To study metabolism changes of your cells o Banking

Participants in the group 1 will receive standard of care treatment for 12 months and may choose to participate in the STAND clinic for up to 12 months. Participants in group 2 will participate in the STAND clinic for 12 months. Participants in the STAND clinic will be followed for an additional 6 months after completion of the STAND clinic.
Clinical trial: NCT02168062
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT02168062
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Related To Study Procedures|What Happens If I Am Injured Because I Took Part In This Study?|Risks

Randomization Risks: You will be assigned to a study arm by chance, and the treatment you receive may prove to be less effective than the other study. Blood Drawing (venipuncture) risks: Drawing blood may cause temporary discomfort from the needle stick, bruising, and infection. Bioelectrical Bioimpedance Device for Assessment of Body Fat risks: The weak electrical current used to your body fat is not felt while using the monitor. Do not use, or allow others to use, this monitor if fitted with a cardiac pacemaker or other medical device. Pregnant women should not use this device Quality of Life (QOL) Questionnaires risks: Answering the Quality of Life questionnaire may be an inconvenience. Some of the questions may remind you of unpleasant aspects of your therapy or disease, and you may experience some discomfort, anxiety or distress in answering such questions. You are free to decline to answer any questions you do not wish to answer, or to stop participating at any time. Bone Mineral Density Scan (DXA) risks: The scanner uses beams of low energy radiation to determine the density of the bone or for soft tissue analysis. Radiation risks: This research study involves exposure to radiation from two DXA Scans and two optional CT scans of the radius/tibia. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation that you will receive as a result of participating in this study will be less than the yearly natural background radiation in the US, which is 3 mSv (a mSv, or milliSievert, is a measurement of radiation). This amount of radiation involves minimal risk. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study. Unknown risks: It is possible that unexpected side effects could occur or that the side effects could be more severe than anticipated. At this time, all the side effects of these  
  
treatments are not known. Patients must report any unusual symptoms to their doctor immediately.  
For more information about risks and side effects, ask your study doctor.

It is important that you tell your study doctors, Dr. Aggarwal, MD, and his associates, if  
  
you feel that you have been injured because of taking part in this study. You can tell him in person or call him . Treatment and Compensation for Injury: If you are injured as a result of being in this study, the University of California will provide necessary medical treatment. The costs of the treatment may be billed to you or your insurer just like any other medical costs, or covered by the University of California depending on a number of factors. The University does not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Committee on Human Research at 415- 476-1814.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.
Clinical trial: NCT02168062
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study?|All Patients Will Have The Following Visits Day 1 (The Visit Will Take About 1 Hour)|The Following Will Be Done At The End Of Every 3 Months (The Visit Will Take About 1 Hour):|Patients In Group 2 (Stand Clinic), Will Have The Following Additional, Monthly Visits.

Participants in this study who are not receiving current chemotherapy will be randomized into 1 of 2 groups. Randomization means that you are put into a group by chance (like rolling dice). A computer program will place you in one of the groups. Neither you nor your doctor can choose the group you will be in. You will have an equal (one in two) chance of being placed in any group. If you are placed in group 1 (standard of care treatment), you will have clinic visits every 3 months and receive current standard of care therapy outlined above. During the visits there will be:
A review of your medical history and current medications  
Assessment of the impact of hormone therapy on body composition and certain laboratory tests (e.g. fasting cholesterol levels)
Toxicity assessment Lifestyle modification counseling and review of quality of life and side effects of androgen deprivation therapy (ADT; ie. hormone therapy) with questionnaires by a trained nurse practitioner and/or physician. Quality of life questionnaires cover various items including your mood, energy level, severity of hot flashes, and overall functional level. The questionnaires will take approximately 20-30 minutes to complete, and can be completed electronically prior to your visit or on paper during the course of your visit. The PHQ-9 questionnaire screening for depression will be completed in person during your study visit.  
Medication management including hormone injections Referrals to exercise, nutrition and symptom management services upon patient request or if deemed necessary by your health care provider. You will have the option of visiting with each of these services as many times as necessary during the course of the study.
After 12 months on study, patients in group 1 will have the opportunity to participate in the STAND clinic for the next 12 months or for the duration of their hormone therapy treatment.  
If you are placed in group 2 (STAND clinic), in addition to visits with your health care provider every 3 months and assessments as outlined above, you will participate in the STAND clinic. The STAND clinic consists of monthly clinic visits in which you will see the following services on a rotating basis:  
Nutrition counseling Exercise training Symptom management by trained physician and/or nurse practitioner  
  
In addition, every month you will view an education "module" during your visit, consisting of Powerpoint slide presentations covering the various aspects of hormone therapy. All patients currently receiving or planning to receive chemotherapy will be placed into Group 2 (STAND clinic).

Physical exam Height, weight, body mass index, and percent body fat measurement LHRH Analogue (hormone injection). If you have already started hormone therapy, you will be kept on the same schedule as before and may not receive hormone injection on the day 1 study visit. Hormone therapy can include Eligard, Zolodex, Trelstar, or Leuprolide Acetate; you and your doctor will discuss which brand you receive. There are no significant differences in treatment effect nor side effects between brands.  
Blood (about 1-2 tablespoons) will be drawn for o Fasting lipid/glucose panel and insulin level o Hemoglobin A1c (to measure glucose levels)
o Serum 25-(OH) vitamin D level o Serum PSA –a protein produced by the prostate gland, that is used to monitor treatment response o Serum testosterone
You will need to fast for at least 10 hours prior to the blood draw.  
Review of medications that you are taking Questions about how your disease is affecting your daily life Quality of life questionnaires Questions about your nutritional habits. Blood (about 1 tablespoon) will be drawn for:
o Studying metabolism changes of your cells which may help researchers understand how drug therapies and interventions may be working.  
o Banking - the researchers would like to collect and store (bank) your blood for future research. To protect your privacy, your blood samples will be identified by your subject number, not your name. These samples will be stored at UCSF indefinitely. The researchers and authorized members of this research study will have access to the samples and data collected. The samples will be destroyed when they are no longer needed.  
  
  
Your blood will be used only for research and will not be sold. The research done with your specimens may help to develop new products in the future. You will not be paid for donating blood. If any discoveries or commercial products are made as a result of research done on your blood, neither you nor your family will receive any financial benefits or compensation. In the future, we may give your specimens and certain medical information about you (for example, diagnosis, blood pressure, age if less than 85) to other scientists or companies not at UCSF, including to a government health research database, but we will not give them your name, address, phone number, or any other information that would identify you. Reports about any research will not be given to you or your doctor.  
Sometimes specimens are used for genetic research (about diseases that are passed on in families). Even if we use the specimen for genetic research, we will not put the results in your medical record. The research will not change the care you receive. Your personal health information cannot be used for additional research without additional approval from either you or a review committee.  
o Optional blood collection to examine genetic changes. Please refer to
"Using Blood for Research" section at end of form.

Physical exam Weight, body mass index, and percent body fat measurement LHRH analogue (hormone injection) Referral to Nutrition, Exercise, and Symptom Management Services upon your request or if deemed necessary by your health care provider Counseling with health care provider to discuss lifestyle modifications, review laboratory results Blood (about 1-2 tablespoons) will be drawn for o Fasting lipid/glucose panel and insulin level o Hemoglobin A1c (to measure glucose levels) o Serum 25-(OH) vitamin D level o Serum PSA
You will need to fast for at least 10 hours prior to the blood draw. Research Procedures:  
  
Review of medications that you are taking Questions about how your disease is affecting your daily life Quality of life questionnaires Measurement of exercise patterns (accelerometer) during month 6 Blood (about 1 tablespoon) will be drawn for:
o To study metabolism changes of your cells o Banking

During the course of these monthly visits, there will be a series of self-guided educational modules discussing various aspects of ADT and management of side effects. These modules will be a series of PowerPoint slides that you view during your visit. You will have the opportunity to ask questions before and after you view each module. These will also be available to all patients for review outside of the clinic. You will have individualized sessions with exercise physiologist, registered dietitian, and symptom management services. You will see one of these providers each month on a rotating basis for the 12 month duration of the clinic. In total, you will visit with each service four times during the course of the year. The STAND clinic visits will take about 1-2 hours.
Clinical trial: NCT02168062
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to determine how to best improve health outcomes and manage the potential side effects of hormone therapy. Side effects of hormone therapy include hot flashes, fatigue, decreased interest in sex, loss of bone density, weight gain, and mood changes, among others. Our current approach to address these issues is to evaluate patients in clinic every 3 months, perform counseling and education during the course of the visit, and if necessary, refer patients to exercise, nutrition, and/or symptom management services. The STAND clinic was created to offer a structured approach for men receiving hormone therapy. Clinic participation consists of monthly visits with Nutrition, Exercise, and Symptom Management services on a rotating basis, as well as self-directed patient education sessions. It is not known whether participation in a structured program such as the STAND clinic, versus the current approach outlined above, leads to better outcomes with respect to potential side effects of hormone therapy. This study is being done to compare these two approaches and help decide which is better in improving the following factors: changes in your percentage body fat and factors that affect your metabolism, your bone health, and your quality of life.
Clinical trial: NCT02168062
Section: Voluntary Participation
Subsections: Consent

You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep. You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you. PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled. If you wish to participate in this study, you should sign below.  
  
Witness - Only required if the participant is a non-English speaker Date
Clinical trial: NCT02168062
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop, and they will tell you how to stop safely.  
It is important to tell the study doctor if you are thinking about stopping, so that your doctor can talk about what follow-up care and testing could be most helpful for your cancer treatment. The study doctor may stop you from taking part in this study at any time if they believe it is in your best interest, if you do not follow the study rules, or if the study is stopped.