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 (IDEA-P)
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| ClinicalTrials.gov Identifier: NCT02050906 |
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Recruitment Status :
Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : June 8, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Prostate Cancer Stage IV Prostate Cancer | Behavioral: behavioral dietary intervention Behavioral: exercise intervention Other: behavioral activity counseling Behavioral: telephone based counseling Procedure: quality-of-life assessment Other: questionnaire administration | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 32 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Intensive Diet and Exercise Adherence Trial - Pilot (IDEA-P): A Feasibility Study of a Lifestyle Intervention in Men Undergoing Androgen Deprivation Therapy |
| Actual Study Start Date : | May 21, 2013 |
| Actual Primary Completion Date : | July 29, 2015 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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: 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: 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. Other: behavioral activity counseling Undergo behavioral activity and nutritional counseling
Other Name: counseling and communications studies Behavioral: telephone based counseling Undergo behavioral activity and nutritional counseling Procedure: quality-of-life assessment Ancillary studies
Other Name: quality of life assessment Other: questionnaire administration Ancillary studies |
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Active Comparator: 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.
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Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment Other: questionnaire administration Ancillary studies |
- Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy [ Time Frame: Baseline to up to 3 months ]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.
- Change in functional performance assessed using the 400 meter walk, stair-climb, and lift and carry task [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to up to 3 months ]
- Change in body weight, measured using a calibrated and certified balance beam scale [ Time Frame: 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) [ Time Frame: Baseline to up to 3 months ]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.
- Change in pain and fatigue, assessed using the short-form McGill Pain Questionnaire and the Brief Fatigue Inventory (BFI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to up to 3 months ]
- Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet records [ Time Frame: 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 [ Time Frame: Up to 3 months ]Descriptive statistics will be calculated prospectively throughout the trial.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with PC: histologically-defined diagnosis of PC based upon providing pathology reports and staging studies
- 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
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): NCT02050906
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Brian Focht, PhD | Ohio State University Comprehensive Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Brian Focht, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02050906 |
| Other Study ID Numbers: |
OSU-12008 NCI-2013-01328 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) R03CA162969 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 31, 2014 Key Record Dates |
| Last Update Posted: | June 8, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
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IDEA-P Androgen Deprivation Therapy |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |