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Behavioral Intervention

Stress Management Program for Depression and Anxiety in Young Adults With Cancer (PRISM Trial)

N/A

Recruiting

Led By Samantha Bento, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be 18-25 years of age

Participants must speak and comprehend English sufficiently to complete study procedures and participate in the program in English

Must not have

Individuals diagnosed with a metastatic disease, diagnosed with cancer less than 6 weeks at the time of screening, or completed cancer treatment more than 6 months ago

Adults unable to consent, individuals who are not yet adults (age <18), pregnant women, and prisoners

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program called PRISM to help young adults with cancer deal with feelings of depression and anxiety.

Who is the study for?

This trial is for young adults with cancer who are experiencing symptoms of depression and anxiety. The study aims to see if a program called PRISM can help manage these psychological symptoms.

What is being tested?

The intervention being tested is the Promoting Resilience in Stress Management (PRISM) Program, which is designed to support young adults with cancer by addressing their depressive and anxiety symptoms.

What are the potential side effects?

Since PRISM is a supportive program focusing on stress management, it does not involve medication or medical procedures; therefore, traditional physical side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 25 years old.

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I can speak and understand English well enough for medical discussions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with metastatic cancer less than 6 weeks ago or finished treatment over 6 months ago.

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I am over 18, can make my own medical decisions, am not pregnant, and not incarcerated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Satisfaction

Rate of PRISM Intervention Completion

Rate of Study Assessment Completion

Secondary study objectives

Questionnaires

mPRISM Phone Application Usage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRISM ProgramExperimental Treatment1 Intervention

Participants will be enrolled and will complete study procedures as follows: * Baseline visit with questionnaires. * 6 weekly or bi-weekly remote or in-clinic, psychotherapy sessions with psychologist. * Final questionnaires and post-study exit interview

0 / 4Eligibility criteria met