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

NCT ID: NCT05369429

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2026-06-01

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.

Detailed Description

Depression is one of the most common psychological comorbidities experienced throughout the cancer continuum. Elevated depressive symptoms in oncology patients is a major concern as unmanaged depressive symptoms in cancer patients is associated with poor health-related quality of life (HRQoL), poor adherence to cancer treatments, delayed return to work and baseline function, greater emergency department visits, and higher all-cause mortality. Behavioral interventions for the management of depression are efficacious, but scalability and implementation of these evidence-based interventions in oncology is limited. Health information technologies (HIT) provide an ideal opportunity to expedite the administration, scoring, and interpretation of depression screening with well-validated, brief and precise measurement tools that can capture actionable data to screen for depression, and deliver pragmatic and scalable evidence-based behavioral interventions that are proven to reduce depressive symptomatology across various other populations.

The study takes place across two distinct health systems in two major metropolitan areas-Chicago and Miami (Northwestern Medicine and University of Miami Health System). While across the two health systems (NM and UHealth), patients already receive EHR-delivered assessments that are linked to EPIC and real-time alerts sent to supportive oncology for patients with moderately to severely elevated symptoms, a lacking component is the integration of an evidence-based, HIT management program for elevated depressive symptoms.

The investigators will evaluate the effectiveness and the implementation of an evidence-based HIT behavioral treatment for cancer patients with elevated depressive symptoms. This HIT treatment combines systematic, electronic health record-integrated screening for depressive symptoms with an individually-tailored HIT interventions to address gaps in the treatment of depression among cancer patients. The investigators' specific aims are as follows:

Aim 1a. To further develop and refine My Wellbeing Guide, a web-based platform to optimize management of elevated depressive symptoms in ambulatory oncology in two large health systems.

Aim 1b. To establish the effectiveness of My Wellbeing Guide on depressive symptoms (i.e., primary outcome) and anxiety, HRQoL, and health services utilization (i.e. secondary outcomes), and putative mechanisms of action/mediators (e.g., self -efficacy) of My Wellbeing Guide on study outcomes compared to usual care.

Aim 1c. To evaluate the process of implementing My Wellbeing Guide and its impact on patient and system-level outcomes through electronic health record (EHR) extractions of Aim 1b patients, and through clinician, and hospital administrator interviews.

Aim 2. To identify facilitators and barriers to wide-scale implementation and expansion of My Wellbeing Guide through interviews and focus groups with stakeholders (clinicians, hospital administrators, and patients who participated in My Wellbeing Guide).

Conditions

Cancer; Anxiety; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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 Type: EXPERIMENTAL

My Wellbeing Guide

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

My Wellbeing Guide

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Betina Yanez

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betina Yanez, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ro Mercer, BS

Role: CONTACT

ro.mercer@northwestern.edu

312-503-3943

Betina Yanez, PhD

Role: CONTACT

betina.yanez@northwestern.edu

3125035341

Facility Contacts

Ro Mercer

Role: primary

ro.mercer@northwestern.edu

3125033943

Other Identifiers

1R37CA255875-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00213537

Identifier Type: -

Identifier Source: org_study_id