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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

R37 Trial 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.Check my eligibility

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.See study design

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.

R37 Trial 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.

R37 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

R37 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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

910,735 Total Patients Enrolled

66 Trials studying Depression

21,909 Patients Enrolled for Depression

University of MiamiOTHER

901 Previous Clinical Trials

403,470 Total Patients Enrolled

29 Trials studying Depression

3,746 Patients Enrolled for Depression

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,919,365 Total Patients Enrolled

81 Trials studying Depression

59,591 Patients Enrolled for Depression

Media Library

My Wellbeing Guide Clinical Trial Eligibility Overview. Trial Name: NCT05369429 — N/A

Depression Research Study Groups: Control, Intervention

Depression Clinical Trial 2023: My Wellbeing Guide Highlights & Side Effects. Trial Name: NCT05369429 — N/A

My Wellbeing Guide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369429 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions for participation in this research project?

"The information on clinicaltrials.gov denotes that this trial is not presently accepting patients; the study was originally listed November 30th 2022 and last updated October 26th 2022. Nonetheless, there are currently 1804 other trials actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life

Betina Yanez 2022. "My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05369429.

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