- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02252484
Energy Balance for Prostate Cancer Survivorship
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
- Diet
- Physical activity
- Coaching
- Diet and exercise monitoring tool
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
- Body Mass Index (BMI) 25-45 kg/m2
- Have internet access
- Have an iPad/iPhone/iDevice
Exclusion Criteria:
- History of 5 alpha reductase inhibitors prior 3 months
- History of radiation therapy
- Taking active cancer treatment
- Undergoing salvage therapy
- Castration-resistant prostate cancer
- Evidence of metastasis
- Evidence of biochemical recurrence
- High risk medical condition (e.g. gout or kidney disease)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Weight loss intervention Group
Participants will receive tailor weight loss program.
Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase).
Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities.
Sessions will be held weekly during the weight loss phase.
The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.
|
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring.
The program is tailored to each individual in the study.
|
Aktiv komparator: Comparison Group
All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
|
Standard of Care for this patient population.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in body weight during the post-surgical period
Tidsram: Change from Surgery to Week 20
|
Change from Surgery to Week 20
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in body weight during the pre-surgical weight-loss intervention
Tidsram: Change from Baseline to Week 8
|
Change from Baseline to Week 8
|
|
Changes in diet quality during the pre-surgical weight-loss intervention
Tidsram: Change from Baseline to Week 8
|
Changes will be measured by analyzing results from alternative healthy eating index scores.
|
Change from Baseline to Week 8
|
Prostate cancer status
Tidsram: Week 20
|
Evidence of recurrence of cancer
|
Week 20
|
Change in cardiovascular biomarkers
Tidsram: Change from Baseline to Week 20
|
Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.
|
Change from Baseline to Week 20
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jill Hamilton-Reeves, PhD, RD, LD, University of Kansas Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00001274
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