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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)

Primary Purpose

Recurrent Prostate Cancer, Stage IV Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavioral dietary intervention
exercise intervention
behavioral activity counseling
telephone based counseling
quality-of-life assessment
questionnaire administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Recurrent Prostate Cancer focused on measuring IDEA-P, Androgen Deprivation Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (diet and exercise intervention)

Arm II (standard of care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in functional performance assessed using the 400 meter walk, stair-climb, and lift and carry task
Change in muscular strength, assessed using standardized one-repetition maximum testing protocols for chest press and leg extension exercises
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
Change in body weight, measured using a calibrated and certified balance beam scale
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.
Change in pain and fatigue, assessed using the short-form McGill Pain Questionnaire and the Brief Fatigue Inventory (BFI)
Change in physical activity assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS), Leisure-Time Exercise Questionnaires, and LIFECORDER Plus Accelerometer
Change in exercise-related self-efficacy, assessed using Exercise Self-Efficacy, Barrier Self-Efficacy, Multi-dimensional, and Self-Regulatory Self-Efficacy scales
Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet records
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2014
Last Updated
September 14, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02050906
Brief Title
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
Acronym
IDEA-P
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2013 (Actual)
Primary Completion Date
July 29, 2015 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer, Stage IV Prostate Cancer
Keywords
IDEA-P, Androgen Deprivation Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (diet and exercise intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (standard of care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
behavioral dietary intervention
Intervention Description
Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
behavioral activity counseling
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Undergo behavioral activity and nutritional counseling
Intervention Type
Behavioral
Intervention Name(s)
telephone based counseling
Intervention Description
Undergo behavioral activity and nutritional counseling
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy
Description
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.
Time Frame
Baseline to up to 3 months
Title
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
Title
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
Title
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
Title
Change in body weight, measured using a calibrated and certified balance beam scale
Time Frame
Baseline to up to 3 months
Title
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)
Description
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.
Time Frame
Baseline to up to 3 months
Title
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
Title
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
Title
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
Title
Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet records
Time Frame
Baseline to up to 3 months
Title
Feasibility of delivering an intensive lifestyle exercise and dietary intervention, assessed using recruitment rates, intervention adherence, adverse events, and retention rates
Description
Descriptive statistics will be calculated prospectively throughout the trial.
Time Frame
Up to 3 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Focht, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31838879
Citation
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.
Results Reference
derived
PubMed Identifier
29684136
Citation
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.
Results Reference
derived
PubMed Identifier
25199619
Citation
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.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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