Clinical trial NCT03406013: Internet-Based Exercise and Diet Support in Prostate Cancer Survivors
Official title: True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Prostate Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Movember Foundation
First posted: 2018-01-23
Enrollment: 206
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accrual success
timeFrame: Up to 3 months
measure: Retention
timeFrame: Up to 6 months
measure: Adherence to the study
timeFrame: Up to 3 months
Secondary outcomes:
measure: Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey
timeFrame: Baseline, 3 months, and 6 months
measure: Harvard T.H. Chan School of Public Health Food Frequency Questionnaire for adults from 2007
timeFrame: Baseline, 3 months, and 6 months
measure: Self-Efficacy for Exercise
timeFrame: Baseline, 3 months, and 6 months
measure: Physical Activity Stage Assessment
timeFrame: Baseline, 3 months, and 6 months
measure: Charlson Comorbidity Index
timeFrame: Baseline, 3 months, and 6 months
measure: Self-Efficacy for Diet
timeFrame: Baseline, 3 months, and 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 3 months, and 6 months
measure: Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
timeFrame: Baseline, 3 months, and 6 months
measure: PROMIS 7-item Short Form - Fatigue
timeFrame: Baseline, 3 months, and 6 months
measure: Behavioral Regulation in Exercise Questionnaire (BREQ2)
timeFrame: Baseline, 3 months, and 6 months
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center-Mount Zion
state: California
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan JM, Van Blarigan EL, Langlais CS, Zhao S, Ramsdill JW, Daniel K, Macaire G, Wang E, Paich K, Kessler ER, Beer TM, Lyons KS, Broering JM, Carroll PR, Kenfield SA, Winters-Stone KM. Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. J Med Internet Res. 2020 Dec 31;22(12):e19238. doi: 10.2196/19238.
citation: Winters-Stone KM, Kenfield SA, Van Blarigan EL, Moe EL, Ramsdill JW, Daniel K, Macaire G, Paich K, Kessler ER, Kucuk O, Gillespie TW, Lyons KS, Beer TM, Broering JM, Carroll PR, Chan JM. Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 15;7(11):e11257. doi: 10.2196/11257.