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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2018-12-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enrolled in group therapy

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

Group Type ACTIVE_COMPARATOR

Group therapy

Intervention Type BEHAVIORAL

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

Surveys

Intervention Type OTHER

MAX-PC, GAD and FACT-P

Not enrolled in group therapy

Patients in control arm will be issued surveys

Group Type PLACEBO_COMPARATOR

Surveys

Intervention Type OTHER

MAX-PC, GAD and FACT-P

Interventions

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Group therapy

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

Intervention Type BEHAVIORAL

Surveys

MAX-PC, GAD and FACT-P

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes