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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

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 • NCT02066181

73%

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Acute kidney injury

Blurred vision

Hemorrhoids

Hypothyroidism

Urticaria

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,738 Total Patients Enrolled

96 Trials studying Prostate Cancer

29,740 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,603 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

1,581 Total Patients Enrolled

Media Library

Quality-of-Life Assessment Clinical Trial Eligibility Overview. Trial Name: NCT03575832 — N/A

Prostate Cancer Research Study Groups: Supportive care (exercise, nutrition counseling)

Prostate Cancer Clinical Trial 2023: Quality-of-Life Assessment Highlights & Side Effects. Trial Name: NCT03575832 — N/A

Quality-of-Life Assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575832 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participation in this trial?

"Affirmative. According to the info hosted on clinicaltrials.gov, this research effort which was originally posted in January 2018 is presently enrolling participants. Approximately 96 individuals need to be recruited from 2 distinct medical facilities."

Answered by AI

What is the current participation rate for this medical experiment?

"Affirmative. Clinicaltrials.gov data indicates the this medical trial is presently recruiting participants at two locations, with a total of 96 patients needed for enrollment. The study was first announced on January 25th 2018 and last revised on September 22nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners

2018. "Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03575832.

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