A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance

NCT03227744 | Terminated

• 1 other identifier: 17314
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] and the General Anxiety and Depression Scale 7 \[GAD-7\] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Anxiety

Outcome Measures

Primary Outcomes (2)

• Assessment of MAX-PC Scores

  Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.

  Change from baseline to 4 weeks to 12 weeks

• Assessment of FACT-P Scores

  Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.

  Change from baseline to 4 weeks to 12 weeks

Secondary Outcomes (1)

• Assessment of anxiety scores as a function of time

  Change from baseline to 4 weeks to 12 weeks

Study Arms (2)

Enrolled in group therapy

ACTIVE COMPARATOR

Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.

Behavioral: Group therapy; Other: Surveys

Not enrolled in group therapy

PLACEBO COMPARATOR

Patients in control arm will be issued surveys

Other: Surveys

Interventions

Group therapy BEHAVIORAL

Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.

Enrolled in group therapy

Surveys OTHER

MAX-PC, GAD and FACT-P

Enrolled in group therapy; Not enrolled in group therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 40
• Primary diagnosis of Prostate Cancer
• Initial MAX-PC score of ≥16.
• Sign a consent form allowing related information to be included in this research.

You may not qualify if:

• Prostate cancer is not their primary diagnosis.
• Have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic medications (e.g., antidepressants, anxiolytics, mood stabilizers.)
• Have been diagnosed with cancer other than prostate cancer (and non-melanoma skin cancer)
• Evidence of active substance abuse.
• Participants in the treatment group who are absent from more than 3 therapy sessions will be excluded.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders

Interventions

Psychotherapy, Group; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aaron Pinkhasov, MD

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 24, 2017
• Study Start: April 19, 2017
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)