Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

NCT02969577 | Completed DMC

• 2 other identifiers: STUDY00004205R01NR014518
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Conditions

Prostate Cancer

Keywords

Androgen deprivation therapy; ADT

Outcome Measures

Primary Outcomes (1)

• Change in LDL

  Change from Baseline to Month 12

Secondary Outcomes (10)

• Change in Body Mass Index (BMI)

  Change from Baseline to Month 6

• Change in Body Mass Index (BMI)

  Change from Baseline to Month 12

• Change in Lipid Profile

  Change from Baseline to Month 6

• Change in Lipid Profile

  Change from Baseline to Month 12

• Change in Waist/Hip Circumference

  Change from Baseline to Month 6

Study Arms (2)

Staying Strong & Healthy Intervention (SS&H)

EXPERIMENTAL

Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.

Behavioral: Exercise Program; Behavioral: Diet and Nutrition Coaching; Other: Usual Care with Attention

Usual Care with Attention (UCA)

ACTIVE COMPARATOR

Participants will receive the usual care they would normally receive if not taking part in this study.

Other: Usual Care with Attention

Interventions

Exercise Program BEHAVIORAL

Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.

Staying Strong & Healthy Intervention (SS&H)

Diet and Nutrition Coaching BEHAVIORAL

Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.

Staying Strong & Healthy Intervention (SS&H)

Usual Care with Attention OTHER

Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

Staying Strong & Healthy Intervention (SS&H); Usual Care with Attention (UCA)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with prostate cancer
• Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
• Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
• Able to speak and read in English or Spanish
• Reachable consistently by telephone
• Able to travel to KUMC

You may not qualify if:

• Not diagnosed with prostate cancer
• Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
• Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
• Not able to speak and read in English or Spanish
• Not reachable consistently by telephone
• Not able to travel to the study site for data collection

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Resistance Training; Diet

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sally Maliski, PhD, RN, FAAN

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: March 7, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 31, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (2)