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Trial record 70 of 1543 for:    Androgens

Living Well on Androgen Deprivation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02108613
Recruitment Status : Unknown
Verified April 2014 by British Columbia Cancer Agency.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
The Prostate Centre - Vancouver Island and the Gulf Islands
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief Summary:
Approximately half of men treated for prostate cancer will be offered hormone deprivation therapy during their cancer experience. The secondary effects of this treatment can result in osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To promote healthy lifestyle choices for couples and maintain their intimacy and emotional health we propose the Living Well, an innovative program that combines nutrition, physical activity, and sexual health initiatives in one integrated service. This project will be piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six month period both the experimental and control groups will have access to a workbook (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health counseling. The experimental group will also have access to an exercise and a nutritional program and support by volunteers to keep motivated. Assessment will look at quality of life, physical factors, and biomarkers associated with secondary disease.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Exercise Sessions Behavioral: Nutrition Education Behavioral: Peer Support Volunteer Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Living Well on Androgen Deprivation Therapy: A Comprehensive Approach to Prostate Cancer Survivorship
Study Start Date : April 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention
The intervention arm will receive sexual health counselling, exercise sessions, nutrition education, and will be assigned a peer support volunteer.
Behavioral: Exercise Sessions
8 weeks of weekly exercise classes taught by a certified exercise physiologist.

Behavioral: Nutrition Education
Four monthly education sessions on nutrition topics. Presentations and materials are were created by a BCCA dietitian.

Behavioral: Peer Support Volunteer
Participants will be assigned a peer support volunteer who will preform adherence calls to discuss goals and motivations about improving exercise and healthy eating.

No Intervention: Control
The control group will receive sexual health counseling.



Primary Outcome Measures :
  1. Change from baseline in participant's quality of life on the Functional Assessment of Chronic Illnesses Therapy (FACT-P) [ Time Frame: Baseline, 6 months, 12 months and 24 months ]
    Functional Assessment of Chronic Illnesses Therapy is a quality of life questionnaire for patients.with prostate cancer.

  2. Change from baseline in patient's partner quality of life on the Quality of Life Scale (QOLS) [ Time Frame: Baseline, 6 months,12 months, 24 months ]
    The Quality of Life Scale is a quality of life questionnaire that will be used for participants partners.

  3. Change from baseline in fatigue on the Functional Assessment of Chronic Illnesses Therapy- Fatigue (FACIT-fatigue) [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    The Functional Assessment of Chronic Illnesses Therapy is a measure of fatigue. This outcome will be tested for both participants and their partners.


Secondary Outcome Measures :
  1. Change from baseline in intimacy on the Dyadic Adjustment Scale (DAS) [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    The Dyadic Adjustment Scale is to measure intimacy. Both participants and their partners will complete this measure.


Other Outcome Measures:
  1. Change from baseline in Body-Mass Index [ Time Frame: Baseline, 3 months, 6 months, 12 months and 24 months ]
    Patient's weight and height will be measured at each meeting with the nurse. Body-Mass index [mass(kg)/height (m)2] will be calculated at each time point

  2. Change from baseline in waist circumference [ Time Frame: Baseline, 3 months, siz months, 12 months and 24 months ]
    Patient's waist circumference will be measured at each meeting with the nurse.

  3. Change from baseline in grip strength [ Time Frame: Baseline, 3 months, 6 months, 12 months and 24 months ]
    Patient's grip strength will be measured at each meeting with the nurse.

  4. Changes from baseline in systolic blood pressure [ Time Frame: Baseline, 3 months, 6 months, 12 months and 24 months ]
    Patient's blood pressure will be measured at each meeting with the nurse.

  5. Change from baseline on blood levels of cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), total glucose (TG), fasting glucose and glycated hemoglobin (HbA1) [ Time Frame: Baseline, 12 and 24 months ]
    Blood measures will be obtained from patient's health records. Blood measures obtained within 12 months prior to starting the program will be used as baseline. Monitoring of these parameters are part of the standard of care.

  6. Change in erectile dysfunction from baseline on the Sexual Health Inventory for Men (SHIM) [ Time Frame: Baseline, 3 months, 6 months, 12 months and 24 months ]
    SHIM results will be obtained from patient's health records. Monitoring erectile dysfunction using this tool is part of the usual care.

  7. Perceptions of patients and partners about the impact of the program on their psychosocial health assessed though qualitative interviews and program's meetings [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    Interviews will be conducted until saturation at baseline (expected n=10) and the same couples will be interviewed again at the other time points. During these interviews qualitative data will be collected and transcribed for analysis. Questions related to their current physical activity experience, nutritional habits and barriers to maintaining a healthy diet and regular physical activity routine will be asked. In addition interviews with intervention participants will ask questions related to participants' satisfaction with the timing, quality, relevance & usefulness of topics discussed during the physical activity and nutrition sessions, motivation provided by instructors and peer volunteers and overall feedback about the program.

  8. Operational impact of the program assessed though interviews with participants, peer-support volunteers, and health care providers and program documentation [ Time Frame: Baseline, 3 months and 6 months ]
    • Operational impact - assessed though interviews with participants, peer-support volunteers, and health care providers, as well as any documentation related to the availability of space and personnel to conduct the program. Finally, direct costs of the program (ie. average salaries of qualified exercise professionals, materials, fitness equipment, etc.) will be obtained from available government economic data and project's expenditures.

  9. Change from baseline on blood levels of Prostate-specific antigen (PSA) and testosterone [ Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months ]
    Blood measures will be obtained from patient's health records. Blood measures obtained within 12 months prior to starting the program will be used as baseline. Monitoring of these parameters are part of the standard of care.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All prostate cancer patients registered with BCCA-VIC or referred by an urologist that are prescribed to receive androgen deprivation in their care plan (not currently on hormone therapy)
  • Must provide written, informed consent
  • Must be able to understand, speak, read and write English, and have the cognitive capacity to complete written questionnaires
  • Must be deemed ready to become more physically active, as determined by the PAR-Q+ and, if required, screened by a Canadian Society for Exercise Physiology Certified Exercise Physiologist® (CSEP-CEP) or medical doctor.
  • Must be willing and able to attend the introductory meeting with the Prostate Centre nurse (baseline measurement recordings), 8 weeks of supervised exercise, 4 monthly nutrition meetings, two sexual health meetings (which includes measurement recording sessions at 6 months), and follow up at 12 and 24 months
  • Must have access to a telephone
  • Must be able to commit to the full 6 month intervention period of the study (i.e. no scheduled, extended absences) and follow up at 12 and 24 months. This does not preclude any participants from withdrawing from the study at any point.
  • Must have greater than 12 months life expectancy

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years [for example, carcinoma in situ of the oral cavity is permissible]
  • Previous hormone therapy within the past 5 years
  • Participants who do not meet the following PAR-Q+(26, 27) criteria will be excluded from the study:
  • Must not have a YES response to Q2 on pg1: Do you feel pain in your chest at rest, during your daily activities of living, OR when you do physical activity?
  • Must not have a YES response to Q7 on pg 1: Has your doctor ever said that you should only do medically supervised physical activity?
  • Must not have YES response to any sub-questions on pages 2-3 related to musculoskeletal conditions, diabetes, heart disease, mental health problems or learning difficulties, pulmonary conditions, spinal cord injury, stroke unless clearance is provided by a CSEP-CEP . A CSEP-CEP will only provide clearance to a positive response if upon further query it is determined that the participant is asymptomatic and the benefits of light to moderate intensity exercise outweigh any foreseeable health and injury risks. In such cases where the CSEP-CEP makes a professional determination that the foreseeable risks may outweigh the benefits of exercise or the participant does not know the necessary details of his or her own medical condition, then the participant will need to obtain clearance via the physician referral letter.
  • PARQ+ form must be signed and dated within 6 months of entry into study
  • More than 80 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108613


Contacts
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Contact: Helena Daudt, PhD 2505195512 hdaudt@bccancer.bc.ca

Locations
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Canada, British Columbia
BC Cancer Agency Not yet recruiting
Victoria, British Columbia, Canada, V*R 6V5
Principal Investigator: Jennifer Goulart, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
The Prostate Centre - Vancouver Island and the Gulf Islands
Investigators
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Principal Investigator: Jennifer Goulart, MD British Columbia Cancer Agency
Principal Investigator: Satnam Sidhu, RD British Columbia Cancer Agency

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02108613     History of Changes
Other Study ID Numbers: 084902
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by British Columbia Cancer Agency:
Androgen deprivation therapy
Supportive care
Quality of life
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs