CancerR37NCT05369429
My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life
A study testing My Wellbeing Guide in people with Cancer and Anxiety, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Anxiety, Depressive Symptoms
- What is being tested?
- My Wellbeing Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,516 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 5 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Note: The investigators will not include any vulnerable populations in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Ro Mercer, 3125033943, ro.mercer@northwestern.edu
About this study
Official title: My Wellbeing Guide, Technology Facilitated Behavioral Intervention for Depression Among Diverse Patients in Ambulatory Oncology
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.
Read the 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
- Being tested
- My Wellbeing Guide
- Keywords
- eHealth, Wellbeing
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Wellbeing GuideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire is a previously validated patient-report measure of symptoms of anxiety in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of anxiety.
Measured: 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)
The Functional Assessment of Cancer Therapy - General - 7 item version (FACT-G7) has been used extensively to measure Health Related Quality of Life (HRQoL). The FACT-G7assesses participant's wellbeing in physical, emotional, social, and functional concerns in the last seven days using a five-point response scale. Scores range from 0-28, with higher scores indicating better quality of life.
Measured: T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start2 Dec 2022
- Primary completion5 Jul 2028 (estimated)
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Betina Yanez, Northwestern University
- Investigators
- Betina Yanez, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369429
- Sponsor's protocol ID
- STU00213537
- Other IDs
- 1R37CA255875-01
- Acronym
- R37
- Status last verified
- May 2026
- First submitted
- 29 Apr 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Wellbeing Guide, Technology Facilitated Behavioral Intervention for Depression Among Diverse Patients in Ambulatory Oncology
- ClinicalTrials.gov ID
- NCT05369429
- Acronym / sponsor ID
- R37 / STU00213537
- Conditions
- Cancer, Anxiety, Depressive Symptoms
- Keywords
- eHealth, Wellbeing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,516 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 5 Jul 2028 (estimated)
- Study completion
- 5 Jul 2028 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: My Wellbeing GuideThe 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Note: The investigators will not include any vulnerable populations in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Wellbeing GuideThe 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. | Behavioural | Intervention |
Primary outcome
Change in depressive symptoms will be evaluated with the Patient-Reported Outcomes Measurement Information System Depression
Time frame: T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)
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.
2 secondary outcomes
Change in anxiety will be evaluated with the Patient-Reported Outcomes Measurement Information System Anxiety
Time frame: 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)
Time frame: T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Betina Yanez, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Wellbeing Guide in people with Cancer and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ro Mercer, BS (312-503-3943, ro.mercer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms will be evaluated with the Patient-Reported Outcomes Measurement Information System Depression (time frame: T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.