Quality-of-Life Assessment for Stage I Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage I Prostate Cancer+8 MoreQuality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Stage I Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage II Prostate Cancer
  • Stage IIIA Prostate Cancer
  • Stage IIIB Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 8 months

Up to 8 months
Elements of the intervention that were successful and/or need improvements
Intervention adherence
Recruitment and retention
Surveillance lifestyle

Trial Safety

Safety Progress

1 of 3

Side Effects for

Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
48%Blood or bone marrow
42%Metabolic or laboratory-testing result
40%Hepatic
36%General
28%Constitutional symptoms
26%Neurologic
22%Pulmonary
21%Gastrointestinal
19%Renal or genitourinary
19%Arrhythmia
13%Pain
8%Infection or febrile neutropenia
7%Skin
7%Musculoskeletal
2%Death
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT00019682) in the Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) ARM group. Side effects include: Blood or bone marrow with 48%, Metabolic or laboratory-testing result with 42%, Hepatic with 40%, General with 36%, Constitutional symptoms with 28%.

Trial Design

1 Treatment Group

Supportive care (exercise, nutrition counseling)
1 of 1

Experimental Treatment

96 Total Participants · 1 Treatment Group

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · N/A

Supportive care (exercise, nutrition counseling)Experimental Group · 5 Interventions: Telephone-Based Intervention, Informational Intervention, Counseling, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Behavioral, Other, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2018
Completed Phase 2
~3250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 months

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,283 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,415 Total Patients Enrolled
32 Trials studying Stage I Prostate Cancer
1,932 Patients Enrolled for Stage I Prostate Cancer
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
2,020 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: