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

NYU Langone Health

Status: Terminated

Conditions: Prostate Cancer

Treatments: Behavioral: Group therapy; Other: Surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT03227744

17314

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups, including a placebo group

Enrolled in group therapy

Active Comparator group

Description:

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

Treatment:

Other: Surveys

Behavioral: Group therapy

Not enrolled in group therapy

Placebo Comparator group

Description:

Patients in control arm will be issued surveys

Treatment:

Other: Surveys