Prostate CancerNCT03227744
A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
A study testing Group therapy and Surveys in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Group therapy and Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Group therapy, Surveys
- Keywords
- Prostate Cancer, Anxiety
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group therapyBehavioural
Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.
SurveysOther
MAX-PC, GAD and FACT-P
| Study group | Role | What they receive |
|---|---|---|
| Enrolled in group therapy | Active comparator | Patients in the group therapy arm will be enrolled in group therapy and be issued surveys. Receives: Behavioral: Group therapy; Other: Surveys |
| Not enrolled in group therapy | Placebo comparator | Patients in control arm will be issued surveys Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 4 weeks to 12 weeks
Secondary outcomes (1)
Assessment of anxiety scores as a function of time
In secondary analysis, a mixed effects model will be used when the outcome vector consists of all three measurements (baseline, 4 and 12 weeks) and via statistical contrasts will examine whether the relationship between PSA anxiety scores and time is linear or if the effect of intervention on anxiety scores is fully observed by week 4. Two-sided p-values ≤ 0.05 will be considered statistically significant.
Measured: Change from baseline to 4 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start19 Apr 2017
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Why it stopped: Study has been terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Pinkhasov, MD, Principal investigator, NYU Winthrop Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227744
- Sponsor's protocol ID
- 17314
- Status last verified
- Feb 2019
- First submitted
- 30 Jun 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
- ClinicalTrials.gov ID
- NCT03227744
- Acronym / sponsor ID
- 17314
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrolled in group therapy | Active comparator | Behavioral: Group therapy, Other: SurveysPatients in the group therapy arm will be enrolled in group therapy and be issued surveys. |
| Not enrolled in group therapy | Placebo comparator | Other: SurveysPatients in control arm will be issued surveys |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group therapyTwelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety. | Behavioural | Enrolled in group therapy |
| SurveysMAX-PC, GAD and FACT-P | Other | Enrolled in group therapy, Not enrolled in group therapy |
Primary outcome
Assessment of MAX-PC Scores
Time frame: Change from baseline to 4 weeks to 12 weeks
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.
Assessment of FACT-P Scores
Time frame: Change from baseline to 4 weeks to 12 weeks
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.
1 secondary outcome
Assessment of anxiety scores as a function of time
Time frame: Change from baseline to 4 weeks to 12 weeks
Results and safety
The study was stopped early (reason given: Study has been terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Pinkhasov, MD principal investigator
NYU Winthrop Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group therapy and Surveys in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study has been terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of MAX-PC Scores (time frame: Change from baseline to 4 weeks to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.