רדאר קליני AI | ||
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הניסוי הקליני NCT02194387 עבור Body Mass Index 25 or Greater, מוטציה בגן BRCA1, מוטציה בגן BRCA2, קרצינומה בשד, שורד סרטן, לוקמיה לימפוציטית כרונית, עייפות, מצב בריאותי לא ידוע, תסמונת לינץ', קרצינומה שחלתית, עודף משקל הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מרכז הסרטן אם. די. אנדרסוןEnergy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I) II. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive individuals and their family members. (Pilot II) III. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (chronic lymphocytic leukemia) patients. (Pilot III)
SECONDARY OBJECTIVES:
I. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot II) III. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot III)
EXPLORATORY OBJECTIVES:
I. To examine relationship between individual-level (e.g., distress) and family-level (e.g., shared mutation status) variables that are specific to high-risk families and the effectiveness of energy balance interventions. (Pilot II)
OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups using a randomized factorial design.
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone application (app).
After completion of study, patients are followed up at 4 months.
Pilot Tests to Optimize the Delivery of Energy Balance Interventions
- 2014-0230
- NCI-2015-00095 (מזהה רישום) (CTRP (Clinical Trial Reporting Program))
- 2014-0230 (מזהה אחר) (M D Anderson Cancer Center)
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיSupportive care (energy balance interventions) TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app. | התערבות תזונתית Record dietary intake 4-7 days per week התערבות תזונתית Record dietary intake 1 day per week התערבות מבוססת אינטרנט Receive email coaching התערבות מבוססת אינטרנט Participate in social networking ניתוח ביומרקרים מעבדתיים Correlative studies ניהול שאלון Ancillary studies התערבות מבוססת טלפון Receive telephone coaching התערבות מבוססת טלפון Receive text messages |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change in waist circumference (Pilot I) | Expressed as the mean difference. | Baseline to 4 months post-intervention |
Change in waist circumference (Pilot II) | Expressed as the mean difference. | Baseline to 4 months post-intervention |
- PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day
- PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
- PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
- PILOTS I, II AND III: Able to read and write English
- PILOTS I, II AND III: Have access to internet
- PILOT II: BRCA positive OR Lynch syndrome positive individuals
- PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
- PILOT III: CLL survivors
- PILOT III: Has experienced fatigue within the past seven days
- PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
- PILOTS I, II AND III: Women who are pregnant (by self-report)
- PILOTS I, II AND III: Less than 3 months post-surgery
- PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
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