Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8

Prostate Cancer Clinical Trial

— Prostate 8  

Official title:

A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470936
• Other study ID #: 14-13555
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: February 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.

Description:

This is a PI-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer. We will recruit and consent 76 men with prostate cancer at UCSF. The subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months. Subjects will be randomized into two arms (Intervention Group and Control Group). The Intervention Group (N=38) will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive text messages, and be provided with individualized lifestyle recommendations. The Control Group (N=38) will have standard of care and be asked to continue with their usual lifestyle habits. They will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. clinical stage =T3a nonmetastatic prostate cancer within 5 years

2. completion of treatment =3 months prior to enrollment, if not on active surveillance

3. ability to walk unassisted

4. be able to speak and read English

5. ability to navigate websites and email, and have internet access

6. able to travel to UCSF for pre- and post-study blood collection

Exclusion Criteria:

1. any contraindications to moderate or vigorous aerobic exercise

2. psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol

3. reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Lifestyle intervention
Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.

Locations

Country	Name	City	State
United States	University of California, San Francisco (UCSF)	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	American Cancer Society, Inc., Prostate Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kenfield SA, Van Blarigan EL, Ameli N, Lavaki E, Cedars B, Paciorek AT, Monroy C, Tantum LK, Newton RU, Signorell C, Suh JH, Zhang L, Cooperberg MR, Carroll PR, Chan JM. Feasibility, Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer. Eur Urol. 2019 Jan 9. pii: S0302-2838(18)31048-0. doi: 10.1016/j.eururo.2018.12.040. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitbit use	We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility	3 months
Primary	text message use	We will measure the number of text messages responded to that required a reply in the intervention arm only during the study period to assess study feasibility	3 months
Primary	website use - number of days the website was visited	We will measure the total number of days the website was visited in the intervention arm only during the study period to assess study feasibility	3 months
Primary	website use - number of website visits	We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility	3 months
Primary	intervention acceptability	We will assess intervention acceptability via questionnaire at 3 months in the intervention group.	3 months
Primary	self-reported change in health behaviors	We will assess change in health behaviors via questionnaire at baseline and 3 months.	3 months
Secondary	change in physical activity measured by activity monitor	This is assessed via 7-day accelerometer measurements at baseline and 3 months.	3 months
Secondary	change in task self-efficacy	We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.	3 months
Secondary	change in plasma antioxidant Vitamin E	We will assess Vitamin E levels at baseline and 3 months.	3 months
Secondary	change in plasma antioxidant lycopene	We will assess lycopene levels at baseline and 3 months.	3 months
Secondary	change in fasting glucose	We will assess fasting glucose at baseline and 3 months.	3 months
Secondary	change in cholesterol	We will assess cholesterol at baseline and 3 months.	3 months
Secondary	change in hemoglobin A1c	We will assess hemoglobin A1c at baseline and 3 months.	3 months
Secondary	change in C-reactive protein	We will assess C-reactive protein at baseline and 3 months.	3 months
Secondary	change in waist circumference	We will assess waist circumference at baseline and 3 months.	3 months
Secondary	change in weight	We will assess weight at baseline and 3 months.	3 months
Secondary	change in body mass index	We will assess body mass index at baseline and 3 months.	3 months
Secondary	depression	Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.	3 months
Secondary	anxiety	Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months. Trait anxiety completed at baseline.	3 months
Secondary	health-related quality of life	Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.	3 months
Secondary	maintenance or adoption of self-reported behaviors after 1 year	We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.	1 year