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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01328 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R03CA162969 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized pilot clinical trial studies 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. Diet and exercise may help improve physical function and quality of life in prostate cancer patients. It is not yet known whether intensive diet and exercise is more effective than standard of care in improving physical function and quality of life in patients with prostate cancer undergoing androgen deprivation therapy.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (diet and exercise intervention) | Experimental | 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. |
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| Arm II (standard of care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral dietary intervention | Behavioral | Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy | Exploratory analyses of the direct and indirect pathways of the intervention effects on change in FL will be conducted using a structural equation modeling longitudinal panel model approach. | Baseline to up to 3 months |
| Change in functional performance assessed using the 400 meter walk, stair-climb, and lift and carry task | Baseline to up to 3 months | |
| Change in muscular strength, assessed using standardized one-repetition maximum testing protocols for chest press and leg extension exercises | Baseline to up to 3 months | |
| Change in body composition, assessed using the Bod Pod whole-body air displacement plethysmography system and GE Lunar dual-energy X-ray absorptiometry (iDXA) system | Baseline to up to 3 months | |
| Change in body weight, measured using a calibrated and certified balance beam scale | Baseline to up to 3 months | |
| Change in global and disease-specific QOL assessed using the Satisfaction with Life Scale, the Short Form (SF)-36, and the Functional Assessment of Cancer Treatment-Prostate (FACT-P) | Exploratory analyses of the direct and indirect pathways of the intervention effects on change in QOL will be conducted using a structural equation modeling longitudinal panel model approach. | Baseline to up to 3 months |
| Change in pain and fatigue, assessed using the short-form McGill Pain Questionnaire and the Brief Fatigue Inventory (BFI) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Focht, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31838879 | Derived | 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. | |
| 29684136 | Derived | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| exercise intervention | Behavioral | 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. |
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| behavioral activity counseling | Other | Undergo behavioral activity and nutritional counseling |
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| telephone based counseling | Behavioral | Undergo behavioral activity and nutritional counseling |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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| Baseline to up to 3 months |
| Change in physical activity assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS), Leisure-Time Exercise Questionnaires, and LIFECORDER Plus Accelerometer | Baseline to up to 3 months |
| Change in exercise-related self-efficacy, assessed using Exercise Self-Efficacy, Barrier Self-Efficacy, Multi-dimensional, and Self-Regulatory Self-Efficacy scales | Baseline to up to 3 months |
| Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet records | Baseline to up to 3 months |
| Feasibility of delivering an intensive lifestyle exercise and dietary intervention, assessed using recruitment rates, intervention adherence, adverse events, and retention rates | Descriptive statistics will be calculated prospectively throughout the trial. | Up to 3 months |
| 25199619 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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