My Wellbeing Guide for Cancer-Related Depression

(R37 Trial)

Overseen By Ro Mercer, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Vulnerable populations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

6516 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online app called My Wellbeing Guide, designed to help manage depression in people with cancer. The app uses cognitive behavioral therapy (a type of talk therapy) through videos, activities, and written content to reduce depression symptoms. Participants will be randomly assigned to either use the app or receive links to helpful cancer resources. It suits anyone with a cancer diagnosis who has noticed increased feelings of depression and has internet access. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage depression alongside cancer treatment.

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 prior data suggests that this eHealth intervention is safe for patients with cancer-related depression?

Research has shown that My Wellbeing Guide helps cancer patients manage stress and depression. This guide includes animated videos, interactive activities, and written content based on cognitive behavioral therapy, a type of talk therapy that helps people change how they think or act.

Regarding safety, this online program focuses on mental and social support and does not involve any drugs or medical devices, resulting in a very low risk of side effects. Similar studies have generally reported positive experiences with these kinds of programs.

The guide is accessible through an online app, ensuring ease of use and safety. Participants can progress through the program at their own pace, enhancing comfort and safety.

In summary, My Wellbeing Guide is a low-risk program focused on mental health support, designed to be safe and easy to use for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about My Wellbeing Guide for cancer-related depression because it offers a unique approach through cognitive behavioral therapy (CBT) delivered via an online application. Unlike traditional therapies that often require in-person sessions, this treatment provides animated videos, interactive activities, and written content accessible anytime, making it convenient for patients. This digital format not only enhances accessibility but also empowers patients to manage their stress and emotional health at their own pace, potentially improving adherence and outcomes.

What evidence suggests that My Wellbeing Guide might be an effective treatment for cancer-related depression?

Research suggests that the My Wellbeing Guide may help reduce depression in people with cancer. This guide uses cognitive behavioral therapy (CBT), a type of talk therapy, to manage stress and improve mood. Studies have shown that CBT can reduce depression symptoms in cancer patients. Participants in this trial will receive the My Wellbeing Guide, which delivers therapy through animated videos, interactive activities, and written content, all available online. While specific results from this guide are still being collected, it is based on proven methods to combat depression. ^{1 2 6 7 8}

Who Is on the Research Team?

Betina Yanez, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• My Wellbeing Guide

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Depression is common among cancer patients, and it can range from normal emotional responses to serious clinical depression caused by the illness itself.

The review outlines various treatment options for depression in cancer patients, including medications, therapy, and social support, while also addressing the management of suicidal patients and the topic of physician-assisted death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Depression frequently occurs in cancer patients, either as a pre-existing condition or as a result of the cancer diagnosis, highlighting the need for mental health support in this population.

The presence of depression in cancer patients is linked to negative outcomes, including lower treatment compliance, shorter survival rates, longer hospital stays, and a decline in quality of life, which can lead to increased healthcare costs.

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]

The review found that while depression screening tools for cancer patients were assessed in 19 studies, there was no evidence from randomized controlled trials (RCTs) showing that screening improves depression outcomes compared to usual care.

One study indicated that a nurse-delivered intervention for major depressive disorder (MDD) resulted in a moderate reduction in depressive symptoms, but overall, the evidence for the effectiveness of depression screening in cancer care remains inconclusive.

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]

Patients with advanced cancer are significantly more likely to experience an initial major depressive episode (MDE) compared to the general population, with an odds ratio of 27.3, indicating a strong association.

However, having advanced cancer does not increase the likelihood of experiencing a recurrent MDE, suggesting that initial depression screening should be prioritized for these patients rather than focusing solely on those with prior psychiatric histories.

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]

A systematic review of 14 studies involving 1364 participants suggests that antidepressants may reduce depressive symptoms in cancer patients compared to placebo, although the evidence is very uncertain and of low quality.

There was no significant difference in efficacy between different classes of antidepressants, indicating that the choice of medication should be individualized, and further high-quality studies are needed to confirm these findings.

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 systematic review of 10 studies involving 885 participants found very low certainty evidence that antidepressants are not significantly more effective than placebo in treating depressive symptoms in cancer patients, indicating a need for caution in their use.

The review highlighted the lack of high-quality studies and called for more rigorous research to better understand the efficacy and safety of antidepressants in this population, suggesting that treatment should be personalized based on individual patient needs.

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]

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]

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]

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]

In a study of 309 cancer patients with depression, a significant reduction in pain was found to increase the odds of improvement in depression by 12-24%, highlighting the importance of managing pain in these patients.

Demographic factors such as being female, having a newly diagnosed or maintenance/disease-free cancer, fewer comorbid conditions, and higher socioeconomic status were also associated with better depression outcomes over 12 months, suggesting that these factors can help identify patients who may need more intensive treatment.

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]

The Depression Care for People with Cancer (DCPC) program effectively reduced major depression in cancer patients, as shown in the SMaRT Oncology-2 and SMaRT Oncology-3 trials involving 642 participants.

Despite improving depression and quality of life, DCPC did not significantly impact survival rates in cancer patients, indicating that while managing depression is crucial, it may not extend life expectancy.

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36805073/

The My Well-Being Guide study rationale and protocol - PubMed This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000447

The My Well-Being Guide study rationale and protocol This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive ...

3. withpower.com withpower.com/trial/phase-depression-5-2022-658a2

My Wellbeing Guide for Cancer-Related Depression The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed ...

4. clinicaltrial.be clinicaltrial.be/en/details/17166?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

My Wellbeing Guide: a Novel Tool for Managing Stress and... The investigators will evaluate the effectiveness and the implementation of an evidence-based HIT behavioral treatment for cancer patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10846504/

The My Well-Being Guide study rationale and protocol Rates of clinically elevated depressive symptoms among ambulatory oncology patients are higher than in the general population and are associated with poorer ...

6. esmoopen.com esmoopen.com/article/S2059-7029(23)00375-7/fulltext

Anxiety and depression in adult cancer patients If not treated, depression can have serious negative consequences for the recovery of patients and their physical, psychological and social ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368479/

The Impact of Cancer on Mental Health and the Importance ... 30% of patients may experience cancer-related psychological disorders, including anxiety, depression, and post-traumatic stress.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00293

Management of Anxiety and Depression in Adult Survivors ... In comparison with a control group, depression prevalence rates among people with cancer are at least two times higher for unipolar mood ...