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

NCT05369429 | Recruiting DMC

• 2 other identifiers: STU002135371R37CA255875-01
• Study Type: interventional
• Target: 6,516
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment. 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. Participants are randomized into either an intervention application (described above) or a control application (which 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.

Conditions

Cancer; Anxiety; Depressive Symptoms

Keywords

eHealth; Wellbeing

Outcome Measures

Primary Outcomes (1)

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

  The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire is a previously validated patient-report measure of depressive symptoms in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of depression.

  T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)

Secondary Outcomes (2)

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

  T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)

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

  T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: My Wellbeing Guide

Control

NO 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.

Interventions

My Wellbeing Guide BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) having been reached out to by the study team for recruitment; (b) planned treatment and follow-up within the NM or UHealth healthcare system; (c) ≥ 18 years of age; (d) medical chart confirmed diagnosis of a solid or hematological malignancy; (e) elevated depressive symptoms on the PROMIS CAT (score \> or = 55) within the last 3 months; (f) access to the internet; (g) willingness to be randomized; (h) able to read English or Spanish; (i) patients must have signed informed consent prior to registration on study

You may not qualify if:

• Note: The investigators will not include any vulnerable populations in this study.

Sponsors & Collaborators

• Northwestern University: lead
• University of Miami: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Betina Yanez, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ro Mercer, BS

CONTACT

312-503-3943; ro.mercer@northwestern.edu

Betina Yanez, PhD

CONTACT

3125035341; betina.yanez@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 11, 2022
• Study Start: December 2, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)