Prostate Cancer
Conditions
Keywords
Exercise, Diet, Lifestyle, Digital, Text messaging, Coach
Brief summary
The Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.
Detailed description
PRIMARY OBJECTIVE: I. To examine the effects of 2-year exercise and/or diet interventions on time to prostate-specific antigen (PSA) recurrence after RP. SECONDARY OBJECTIVES: I. Assess the proportion of participants with PSA recurrence at 6-, 12-and 24-months post-surgery. II. To examine quality of life (QOL) across intervention groups over time. Outcomes will include sexual and urinary function, anxiety, depression, and overall QOL assessed at all timepoints. III. To examine intervention feasibility measured by intervention component use. IV. To examine exercise and diet behaviors across groups over time using patient reported data and accelerometer data. EXPLORATORY OBJECTIVES: I. To examine mRNA expression pathways/scores in prostate tissue at RP accounting for baseline factors. II. To examine Decipher prognostic scores in RP tissue, accounting for baseline factors. III. To examine longitudinal changes in PSA from baseline to 12 and 24 months. IV. To examine intervention acceptability (self-report: surveys and/or interviews). V. To examine the effect of the interventions on exercise and diet confidence (self-report from surveys and coaching calls). Additionally, investigators will also examine other behavioral constructs in a similar manner (social support, perceived barriers, use of change strategies). VI. To examine changes in blood biomarkers across groups over time, including metabolic markers, CRP, HbA1c, and lipid panel. VII. To examine changes in body weight, and waist and hip circumference across groups over time. The Prostate 8-II study enrolls participants up to 8 weeks prior to surgery. Participants may continue the intervention from time of study entry to 96 weeks after RP surgery. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The remaining 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Participants in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6,12, & 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Participants will be followed for 30 days after completion of the 2-year (24-cycle) intervention period or removal from the study, or until death, whichever occurs first. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for up to 3 additional years.
Interventions
BEHAVIORALExercise and Diet
Behavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D)
Sponsors
University of California, San Francisco
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years 2. Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment. 3. Able to speak and read English 4. Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone 5. Ability to understand a written informed consent document, and the willingness to sign it
Exclusion criteria
1. Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling \>4 weeks prior to RP). 2. Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions: 1. Heart attack 2. Heart surgery, cardiac catheterization, or coronary angioplasty 3. Pacemaker/implantable cardiac defibrillator/rhythm disturbance 4. Heart valve disease 5. Heart failure 6. Heart transplantation 7. Congenital heart disease 8. Diabetes 9. Kidney (renal) disease 10. Chest discomfort with exertion 11. Unreasonable breathlessness 12. Dizziness, fainting, or blackouts 13. Ankle swelling 14. Unpleasant awareness of forceful, rapid or irregular heart rate 15. Burning or cramping sensations in your lower legs when walking short distance 3. Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session 4. Men who are already meeting all of the 7 prostate-specific dietary recommendations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to prostate-specific antigen recurrence | Up to 5 years post-surgery | The median time in months to PSA recurrence after surgery will be evaluated using prespecified biochemical recurrence (2x PSA ≥ 0.2) and detectable (2x PSA ≥ 0.03) PSA thresholds, at the time of analysis. A log-rank test to evaluate the time to recurrence among groups and multivariate Cox proportional hazards regression will be used to obtain a hazard ratio for the time to recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with PSA recurrence over time | Up to 24 months post-surgery | The proportion of participants by group with documented PSA recurrence at months 6, 12 and 24 months post-surgery will be reported along with corresponding 95% confidence intervals. |
| Mean scores on the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL). |
| Mean scores on the urinary function domain of the EPIC-26 over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL). |
| Mean scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. |
| Mean scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better. |
| Mean scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. |
| Mean scores on the 12-Item Short Form Health Survey (SF-12) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS \& MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health. |
| Changes in recorded physical activity over time | Baseline, and 6 months, 12 months, and 24 months post-surgery | Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity |
| Mean scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and \< 14 units "Insufficiently Active/Sedentary". |
| Mean scores in Harvard Food Frequency Questionnaire (FFQ) over time | Baseline, and 6 months, 12 months, and 24 months post-surgery | The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency |
| Frequency of responses on the Intervention feasibility (intervention arms) | Baseline, and 6 months, 12 months, and 24 months post-surgery | Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Descriptive data across arms will be reported. |
| Mean scores on the Pittsburgh Sleep Quality Index (PSQI) over time. | Baseline, and 6 months, 12 months, and 24 months post-surgery | In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacey A Kenfield, DSc
University of California, San Francisco
Outcome results
None listed