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Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

OHSU Knight Cancer Institute logo

OHSU Knight Cancer Institute

Status

Completed

Conditions

Prostate Carcinoma
Cancer Survivor

Treatments

Behavioral: Coaching
Behavioral: Technology
Behavioral: Written Information
Behavioral: Prescription

Study type

Interventional

Funder types

Other

Identifiers

NCT03406013
STUDY00016703 (Other Identifier)
NCI-2017-01048 (Registry Identifier)

Details and patient eligibility

About

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.

Full description

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.

SECONDARY OBJECTIVES:

I. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.

OUTLINE: Patients are assigned to 1 of 4 groups.

GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.

GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.

GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.

GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.

After completion of intervention, patients are followed up at 3 months.

Enrollment

206 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Self-reported prostate cancer diagnosis
  • Able to read English on a computer screen
  • Able to access a computer, tablet or smartphone at home or public location
  • Access to a device capable of receiving plain text messages
  • A personal email address

Exclusion criteria

  • Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria and who do not receive a physician clearance to participate in the moderate intensity physical activity with one or more of the following self-reported conditions:

    • heart attack
    • heart surgery, cardiac catheterization, or coronary angioplasty
    • pacemaker/implantable cardiac defibrillator/rhythm disturbance
    • heart valve disease
    • heart failure
    • heart transplantation
    • congenital heart disease
    • diabetes
    • kidney (renal) disease
    • chest discomfort with exertion
    • unreasonable breathlessness
    • dizziness, fainting or blackouts
    • ankle swelling
    • unpleasant awareness of forceful, rapid or irregular heart rate
    • burning or cramping sensations in your lower legs when walking short distance

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

206 participants in 4 patient groups

Group I
Active Comparator group
Description:
Written Information
Treatment:
Behavioral: Written Information
Group II
Experimental group
Description:
Written Information Prescription
Treatment:
Behavioral: Written Information
Behavioral: Prescription
Group III
Experimental group
Description:
Written Information Prescription Technology
Treatment:
Behavioral: Technology
Behavioral: Written Information
Behavioral: Prescription
Group IV
Experimental group
Description:
Written Information Prescription Technology Coaching
Treatment:
Behavioral: Coaching
Behavioral: Technology
Behavioral: Written Information
Behavioral: Prescription

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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