NCT05369429 My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life
| NCT ID | NCT05369429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,516 participants |
| Start Date | 2022-12-02 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,516 participants in total. It began in 2022-12-02 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Betina Yanez, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05369429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05369429 currently recruiting?
Yes, NCT05369429 is actively recruiting participants. Contact the research team at ro.mercer@northwestern.edu for enrollment information.
Where is the NCT05369429 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05369429 clinical trial?
NCT05369429 is sponsored by Northwestern University. The principal investigator is Betina Yanez, PhD at Northwestern University. The trial plans to enroll 6,516 participants.
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