My Wellbeing Guide for Cancer-Related Depression

(R37 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Betina Yanez, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Vulnerable populations

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a digital therapy program, so it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the treatment My Wellbeing Guide for cancer-related depression?

Research shows that psychotherapeutic interventions can effectively reduce depression symptoms in cancer patients, which may improve their overall health and potentially affect disease progression. ^{1 2 3 4 5}

Is My Wellbeing Guide safe for treating cancer-related depression?

The research mentions that Western medicine antidepressants, which are often used for depression in cancer patients, can have many side effects, leading some patients to stop using them. However, there is no specific safety data available for My Wellbeing Guide in the provided research. ^{6 7 8 9 10}

How is the treatment 'My Wellbeing Guide' different from other treatments for cancer-related depression?

The treatment 'My Wellbeing Guide' is unique because it focuses on integrating practical management tools to help clinicians deliver appropriate care for depression in cancer patients, which may include psychological and collaborative care interventions, rather than relying solely on medications like antidepressants. ^{5 8 11 12 13}

Research Team

Betina Yanez, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

My medical records confirm I have cancer.

Elevated depressive symptoms on the PROMIS CAT (score ≥ 55) within the last 3 months

Access to the internet

Exclusion Criteria

Investigators will not include any vulnerable populations in this study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive cognitive behavioral therapy management strategies for health-related stress via an online application

7 weeks

Baseline assessment, post-intervention assessment

Follow-up

Participants are monitored for depressive symptoms, anxiety, and health-related quality of life

12 months

Assessments at 6 months and 12 months post-intervention

Treatment Details

Interventions

• My Wellbeing Guide (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1674

Patients Recruited

989,000+

University of Miami

Collaborator

Trials

976

Patients Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

Depression is a common psychological issue in cancer patients, negatively affecting their emotional well-being, quality of life, treatment adherence, and overall health outcomes, including immune response and survival rates.

Psychotherapeutic interventions have been shown to effectively reduce depressive symptoms in cancer patients, which may positively influence disease progression and mortality, highlighting the importance of addressing mental health in oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of psychotherapeutic interventions on depression in cancer patients and their impact on disease progression. Barrera, I., Spiegel, D.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study. Cohee, AA., Kroenke, K., Vachon, E., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression screening and patient outcomes in cancer: a systematic review. Meijer, A., Roseman, M., Milette, K., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does depression treatment improve the survival of depressed patients with cancer? A long-term follow-up of participants in the SMaRT Oncology-2 and 3 trials. Mulick, A., Walker, J., Puntis, S., et al.[2019]

The updated guideline emphasizes that adult cancer patients with depression can benefit from both psychological and pharmacologic interventions, but no specific treatment was found to be superior to others.

A new recommendation for a collaborative care model using a stepped care approach suggests that restructuring mental health care may be necessary for better management of depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Depression in Patients With Cancer: A Clinical Practice Guideline. Li, M., Kennedy, EB., Byrne, N., et al.[2022]

A systematic review of nine studies involving 861 participants found very low quality evidence that antidepressants are effective in reducing depressive symptoms in adults with cancer compared to placebo, indicating that their efficacy in this population is uncertain.

Due to the low quality of the studies and the lack of clear evidence, the use of antidepressants for cancer patients should be individualized, and more robust trials are needed to determine their effectiveness and safety in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. Ostuzzi, G., Matcham, F., Dauchy, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced cancer as a risk for major depressive episodes. Meyer, F., Fletcher, K., Prigerson, HG., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. Vita, G., Compri, B., Matcham, F., et al.[2023]

A study involving 120 cancer patients showed that Chaihu plus Longgu Muli decoction combined with five-element music therapy significantly reduced depression scores compared to escitalopram, with a lower Hamilton Depression scale score in the treatment group (13.93 vs 19.04).

The treatment group also had a higher total effective rate (93.33% vs 73.33%) and improved quality of life, indicated by better functional scores and higher levels of serum norepinephrine and serotonin, suggesting a beneficial impact on both mood and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Chaihu plus Longgu Muli decoction plus five-element music therapy in the treatment of cancer-related depression. An, Y., Liu, Z., Wang, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. Ostuzzi, G., Matcham, F., Dauchy, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression and suicide in patients with cancer. Massie, MJ., Gagnon, P., Holland, JC.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression is often undiagnosed in older people with cancer. [2017]

About 30% of cancer patients experience depression, which can arise at critical times such as after diagnosis or during treatment failure, making it a significant concern in cancer care.

Treating depression in cancer patients can enhance their quality of life and treatment satisfaction, with antidepressants being the first-line treatment, while psychotherapy and combined treatments are also effective options for more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment of depression in patients with cancer]. Stagno, D., Stiefel, F., Rousselle, I., et al.[2006]

References

1. England pubmed.ncbi.nlm.nih.gov

Review of psychotherapeutic interventions on depression in cancer patients and their impact on disease progression. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Depression screening and patient outcomes in cancer: a systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Does depression treatment improve the survival of depressed patients with cancer? A long-term follow-up of participants in the SMaRT Oncology-2 and 3 trials. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Management of Depression in Patients With Cancer: A Clinical Practice Guideline. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Advanced cancer as a risk for major depressive episodes. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Effect of Chaihu plus Longgu Muli decoction plus five-element music therapy in the treatment of cancer-related depression. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Antidepressants for the treatment of depression in people with cancer. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Depression and suicide in patients with cancer. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Depression is often undiagnosed in older people with cancer. [2017]

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment of depression in patients with cancer]. [2006]