Intensive Diet and Exercise or Standard of Care in Improving Physical Function and Quality of Life in Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy
NCT ID: NCT02050906
Last Updated: 2024-12-31
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
32 participants
INTERVENTIONAL
2013-05-21
2015-07-29
Brief Summary
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Detailed Description
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I. To compare the effects of the intensive lifestyle intervention and standard of care treatments on functional limitations (FL), body composition (BC), and quality of life (QOL) in prostate cancer (PC) patients on androgen deprivation therapy (ADT).
II. To determine the feasibility of delivering an intensive lifestyle exercise and dietary intervention to PC patients undergoing ADT.
III. To identify the intermediate variables that account for the beneficial effect of the lifestyle intervention on functional limitations and QOL.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I:
EXERCISE COMPONENT: Patients undergo 1 hour of intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12.
BEHAVIORAL ACTIVITY COUNSELING: Patients undergo behavioral activity counseling in small group sessions over 20 minutes once weekly during months 1-2 and individualized activity counseling via telephone calls over 20 minutes every 2 weeks for 3 months.
DIETARY COMPONENT: Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
ARM II: Patients receive standard care and educational literature describing the American Institute of Cancer Research dietary and physical activity guidelines. Patients also receive phone calls over 20 minutes every 2 weeks for 3 months focusing on routine prostate cancer self-management. After 3 months, patients undergo 2 supervised exercise training and dietary counseling sessions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (diet and exercise intervention)
EXERCISE COMPONENT: Patients undergo 1 hour of monitored intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.
BEHAVIORAL ACTIVITY COUNSELING: Patients undergo behavioral activity counseling in small group sessions over 20 minutes once weekly during months 1-2 and individualized activity counseling via telephone calls over 20 minutes every 2 weeks for 3 months. Counseling will include questionnaire administration.
BEHAVIORAL DIETARY INTERVENTION: Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
behavioral dietary intervention
Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
exercise intervention
Patients undergo 1 hour of intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12.
behavioral activity counseling
Undergo behavioral activity and nutritional counseling
telephone based counseling
Undergo behavioral activity and nutritional counseling
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Arm II (standard of care)
TELEPHONE BASED COUNSELING: Patients receive standard care and educational literature describing the American Institute of Cancer Research dietary and physical activity guidelines. Patients also receive phone calls over 20 minutes every 2 weeks for 3 months focusing on routine prostate cancer self-management. After 3 months, patients have the option to undergo 2 supervised exercise training and dietary counseling sessions. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Interventions
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behavioral dietary intervention
Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
exercise intervention
Patients undergo 1 hour of intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12.
behavioral activity counseling
Undergo behavioral activity and nutritional counseling
telephone based counseling
Undergo behavioral activity and nutritional counseling
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initiating ADT: will be initiating a planned course of at least 3 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral antiandrogen therapy such as 5-alpha reductase inhibitors alone or oral antiandrogens alone, as they do not produce castrate levels of testosterone
* Stage: at enrollment, all men have stage IV disease, which is our major presentation to the medical oncology prostate program; two groups are typical; the first involves men who usually present for initial diagnosis with minimally metastatic disease and elevated prostate-specific antigen (PSA) and staging studies with modest nodal enlargement or bone lesions, typically asymptotic; the second group involves men we have been monitoring after local therapy, surgery or radiation, but who have a slow rise in PSA indicating failure of curative therapy; at some point in time asymptomatic metastases are noted on scans, and ADT is offered
* Sedentary lifestyle: fewer than 60 minutes of participation in structured moderate intensity physical activity each week
* Health status: all participants must be free of active cardiovascular disease (CVD), unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe; men with prior CVD that have had successful intervention/treatment that are no longer have active CVD and are medically cleared to safely exercise by their physician will be eligible to participate in the study
* Consents: willing to give an informed consent and sign a Health Insurance Portability and Accountability Act (HIPPA) authorization form
* Physician medical clearance: all men will have medical clearance to participate in the study from a board certified internist, primary care physician, or cardiologist (for men with ongoing cardiovascular disease) prior to inclusion in the study; all participants' treating oncologists will also provide consent for participation prior to inclusion in the study
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Focht, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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Focht BC, Lucas AR, Grainger E, Simpson C, Fairman CM, Thomas-Ahner JM, Chaplow ZL, DeScenza VR, Bowman J, Clinton SK. Effects of a Group-Mediated Cognitive Behavioral Lifestyle Intervention on Select Social Cognitive Outcomes in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419893764. doi: 10.1177/1534735419893764.
Focht BC, Lucas AR, Grainger E, Simpson C, Fairman CM, Thomas-Ahner JM, Buell J, Monk JP, Mortazavi A, Clinton SK. Effects of a Group-Mediated Exercise and Dietary Intervention in the Treatment of Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: Results From the IDEA-P Trial. Ann Behav Med. 2018 Apr 19;52(5):412-428. doi: 10.1093/abm/kax002.
Focht BC, Lucas AR, Grainger E, Simpson C, Thomas-Ahner JM, Clinton SK. The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial. Trials. 2014 Sep 9;15:354. doi: 10.1186/1745-6215-15-354.
Related Links
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The Jamesline
Other Identifiers
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NCI-2013-01328
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-12008
Identifier Type: -
Identifier Source: org_study_id