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My Wellbeing Guide for Cancer-Related Depression (R37 Trial)

N/A

Recruiting

Led By Betina Yanez, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Medical chart confirmed diagnosis of a solid or hematological malignancy

≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (prior to starting intervention), t2 (7 weeks post intervention), t3 (6 months post-intervention), t4 (12 months post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of the intervention on depressive symptoms in patients with cancer over time.

Who is the study for?

This trial is for adults over 18 with a confirmed cancer diagnosis, experiencing elevated depressive symptoms, who are treated within the NM or UHealth systems. Participants must have internet access and be able to read English or Spanish. They should consent to random assignment in the study and not belong to any vulnerable populations.

What is being tested?

The 'My Wellbeing Guide' eHealth intervention is being tested against a control application providing resource links. The guide includes cognitive behavioral therapy strategies delivered online over 7 weeks, aiming to reduce depression in cancer patients. Assessments occur at baseline, post-intervention, and at 6- and 12-month follow-ups.

What are the potential side effects?

Since this intervention involves psychological support through an app rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues related to their condition.

Eligibility Criteria

Inclusion Criteria

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

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My medical records confirm I have cancer.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (prior to starting intervention), t2 (7 weeks post intervention), t3 (6 months post-intervention), t4 (12 months post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (prior to starting intervention), t2 (7 weeks post intervention), t3 (6 months post-intervention), t4 (12 months post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (prior to starting intervention), t2 (7 weeks post intervention), t3 (6 months post-intervention), t4 (12 months post-intervention) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in depressive symptoms will be evaluated with the Patient-Reported Outcomes Measurement Information System Depression

Secondary study objectives

Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy - General - 7 item version (FACT-G7)

Change in anxiety will be evaluated with the Patient-Reported Outcomes Measurement Information System Anxiety

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Group II: ControlActive Control1 Intervention

The control application will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website. Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

0 / 2Eligibility criteria met