Your session is about to expire
← Back to Search
Lifestyle Intervention for Prostate Cancer Quality of Life
N/A
Waitlist Available
Led By Lorna McNeill
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be greater than 18 years of age (patient and spouse or intimate partner)
Have 0-III stage prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights
Study Summary
This trial is studying how well a social support lifestyle intervention (called Watchful Living) works in improving quality of life in African American prostate cancer participants and their partners who are on active surveillance.
Who is the study for?
This trial is for African American or Hispanic couples where one partner has localized prostate cancer (stages 0-III) and is on active surveillance. Both must be over 18, have internet access, not meet physical activity recommendations, and agree to not join other lifestyle programs. Patients should have finished any prior therapy and can't be receiving certain treatments during the study.Check my eligibility
What is being tested?
The 'Watchful Living' program aims to improve quality of life for patients with localized prostate cancer and their partners through a social support lifestyle intervention. It includes telephone-based counseling, educational materials, assessments of well-being, and questionnaires administered over time.See study design
What are the potential side effects?
Since this trial focuses on lifestyle interventions like increased physical activity and dietary changes rather than medication or invasive procedures, side effects are minimal but may include discomfort from new exercise routines or adjustments in diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I and my partner are both over 18 years old.
Select...
My prostate cancer is at stage 0 to III.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention adherence
Recruitment and retention
Secondary outcome measures
Elements of the intervention that were successful and/or need improvements
Surveillance lifestyle
Side effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (exercise, nutrition counseling)Experimental Treatment5 Interventions
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,171 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,250 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,064 Patients Enrolled for Prostate Cancer
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,581 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is at stage 0 to III.I am currently being monitored without active treatment.I am scheduled for additional cancer treatments like immunotherapy or chemotherapy during the study.I have finished all my cancer treatments.I will participate in the trial with my spouse or partner.I and my partner are both over 18 years old.I have had radiation therapy for my initial cancer.I have an active cancer that is not skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (exercise, nutrition counseling)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger