NCT02252484

Brief Summary

The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

September 18, 2014

Last Update Submit

September 6, 2016

Conditions

Prostate Cancer

Keywords

prostate cancerprostatectomyweight lossprevent weight gain

Outcome Measures

Primary Outcomes (1)

  • Change in body weight during the post-surgical period

    Change from Surgery to Week 20

Secondary Outcomes (4)

  • Changes in body weight during the pre-surgical weight-loss intervention

    Change from Baseline to Week 8

  • Changes in diet quality during the pre-surgical weight-loss intervention

    Change from Baseline to Week 8

  • Prostate cancer status

    Week 20

  • Change in cardiovascular biomarkers

    Change from Baseline to Week 20

Study Arms (2)

Weight loss intervention Group

EXPERIMENTAL

Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.

Other: Weight Loss Program

Comparison Group

ACTIVE COMPARATOR

All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.

Other: Standard of Care

Interventions

Weight Loss ProgramOTHER

Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.

Weight loss intervention Group
Standard of CareOTHER

Standard of Care for this patient population.

Comparison Group

Eligibility Criteria

Age50 Years - 72 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
  • Body Mass Index (BMI) 25-45 kg/m2
  • Have internet access
  • Have an iPad/iPhone/iDevice

You may not qualify if:

  • History of 5 alpha reductase inhibitors prior 3 months
  • History of radiation therapy
  • Taking active cancer treatment
  • Undergoing salvage therapy
  • Castration-resistant prostate cancer
  • Evidence of metastasis
  • Evidence of biochemical recurrence
  • High risk medical condition (e.g. gout or kidney disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Hamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9.

    PMID: 33295204DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsWeight Loss

Interventions

Weight Reduction ProgramsStandard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jill Hamilton-Reeves, PhD, RD, LD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 30, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

US(1)