Mental Health Support for Cancer

Overseen By Christian Nelson, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Severe cognitive impairment, Hospice care, Current mental health treatment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to support mental health in older adults diagnosed with cancer and experiencing depression. It compares the regular method of connecting these patients to mental health services with a new approach called Open Door for Cancer (OD-C). The goal is to determine if OD-C is practical and helpful for both patients and healthcare providers. This trial suits those diagnosed with breast, colorectal, lung, or prostate cancer at age 65 or older, who are currently receiving or have recently completed cancer treatment, and are experiencing a depressed mood. As an unphased study, this trial offers a unique opportunity to contribute to innovative mental health solutions for cancer patients.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Open Door for Cancer (OD-C) approach is safe for mental health support in cancer patients?

Research shows that mental health support can greatly benefit cancer patients. Studies indicate that up to 30% of cancer patients may experience mental health challenges such as anxiety or depression. The Open Door for Cancer (OD-C) approach aims to assist these patients through scheduled phone or video calls.

While specific safety data for the OD-C method is not available, mental health support is generally considered safe. The OD-C approach involves discussing issues, a common and well-accepted method in mental health care. No known risks or negative effects are associated with this type of support.

Overall, the OD-C approach is designed to enhance mental health for individuals dealing with cancer. It is non-invasive and focuses on providing emotional support through conversation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Open Door for Cancer (OD-C) approach because it offers a unique, structured mental health support system specifically tailored for cancer patients. Unlike standard care that often depends on the oncology team's discretion for distress screening and referrals, OD-C provides a consistent, proactive approach with scheduled support sessions. This method includes three 30-minute telephone or videoconference visits over six weeks, plus a booster call, ensuring regular check-ins and support. By integrating these structured components, OD-C aims to enhance mental health support for cancer patients, potentially leading to better emotional outcomes.

What evidence suggests that the Open Door for Cancer (OD-C) approach is effective for mental health support in older cancer patients?

Research has shown that mental health support can greatly improve the well-being of cancer patients. For example, peer support programs like Stronger Together have reduced depression and stress while enhancing quality of life. In this trial, participants will receive either the Open Door for Cancer (OD-C) approach or usual care. The OD-C approach, which includes organized support sessions, may assist older adults with depression who have cancer. Additionally, combining mental health services with cancer care is increasingly seen as essential for addressing the unique challenges these patients face. Therefore, OD-C is considered both practical and helpful in improving mental health outcomes for cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Kelly McConnell, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 65 with breast, colorectal, lung, or prostate cancer who are currently in treatment or have finished within the last six months. They must speak English well and show signs of depression. It's not for those severely cognitively impaired, too ill to participate, receiving hospice care, or already in mental health treatment.

Inclusion Criteria

Healthcare providers are involved.

I was diagnosed with breast, colorectal, lung, or prostate cancer at 65 or older.

I have been receiving cancer treatment for at least three years.

Exclusion Criteria

Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11

N/A

Per medical record and/or self-report, currently enrolled in mental health treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Open Door for Cancer (OD-C) intervention, which includes three 30-minute telephone or videoconference visits over six weeks and one booster telephone call.

6 weeks

3 visits (telephone/videoconference), 1 booster call

Usual Care

Participants receive standard care, including distress screening and referrals to mental health services as determined by the oncology team.

Follow-up

Participants are monitored for attrition rates and treatment satisfaction over the course of the study.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Open Door for Cancer (OD-C) approach

Trial Overview

The study tests a new way called OD-C to help older adults with cancer and depressed mood get mental health services. It compares this approach with usual methods by using questionnaires, interviews and regular calls to see if it's helpful for patients and practical for providers.

How Is the Trial Designed?

Group I: Open Door for Cancer (OD-C) Experimental Treatment 1 Intervention

OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.

Group II: Usual Care Active Control 2 Interventions

Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.

Open Door for Cancer (OD-C) approach is already approved in United States for the following indications:

Approved in United States as Open Door for Cancer for:

• Mental health care for adults with depressed mood diagnosed with cancer at age 65 or older

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

This study is evaluating an internet-based cognitive behavioral intervention called CancerCope for patients with cancer experiencing psychological distress, with 163 participants recruited and assessed over 12 months.

The primary focus is on reducing psychological distress and unmet supportive care needs, with initial findings indicating that 50% of participants reported significant distress, highlighting the need for effective psychological support in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope. Chambers, SK., Ritterband, L., Thorndike, F., et al.[2019]

This multicenter study aims to assess the prevalence of mental disorders and psychological distress in cancer patients across various treatment settings in Germany, involving a diverse sample from five major cities.

By using validated screening tools like the PHQ-9 and CIDI-O, the study will identify specific psychosocial support needs and risk factors, which can help tailor interventions to improve the mental health care of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients - study protocol of an epidemiological multi-center study. Mehnert, A., Koch, U., Schulz, H., et al.[2021]

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

Complementary psychotherapy is essential for cancer patients when the stress from their illness and treatment exceeds their coping abilities, aiming to enhance quality of life and manage psychological disorders.

There is a critical need to develop effective strategies that integrate psycho-oncological resources with oncological services, as current support options are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy in cancer patients]. Frick, E.[2007]

Approximately one-third of cancer patients experience mental disorders during their illness, highlighting the need for psychological support throughout treatment.

Psychotherapeutic and psycho-oncological interventions can effectively address mental health issues in cancer patients, suggesting that all patients should be informed about these supportive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer medicine in a state of flux - Where does psycho-oncology stand? : New challenges for cancer patients and treating physicians]. Grigelat, A., Mumm, F.[2023]

The study identified 66 psychosocial oncological (PO) interventions in the Netherlands, with a significant focus on improving psychosocial and physical functioning, highlighting the need for diverse support in cancer care.

Approximately 25% of these interventions lacked scientific evidence, indicating a gap in research that needs to be addressed to ensure effective treatment options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An inventory of psychosocial oncological interventions in The Netherlands: identifying availability, gaps, and overlap in care provision. Spelten, ER., Lammens, CRM., Engelen, V., et al.[2021]

In a study of 32 women with primary ovarian cancer, 44% of those with high psychological distress who consented to mental health intervention were found to have clinically significant psychiatric conditions.

Women with high distress who refused mental health intervention faced more socioeconomic challenges and received fewer initial interventions, suggesting that advanced practice nurses (APNs) can play a crucial role in providing support and managing cancer-related issues for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Distress during Ovarian Cancer Treatment: Improving Quality by Examining Patient Problems and Advanced Practice Nursing Interventions. O'Sullivan, CK., Bowles, KH., Jeon, S., et al.[2023]

A quality improvement project at a comprehensive cancer center successfully reduced the no-show rate for psychiatric oncology appointments by addressing barriers to attendance.

Improving mental health care engagement among cancer patients is crucial, as it enhances their adherence to oncology treatments and leads to better overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Reduce the No-Show Rate in the Psychiatric Oncology Clinic: Clinical Safety and Effectiveness Project. Rashid, A., Rickman, K., Saraykar, S.[2021]

The transition of the Finding My Way program to open access resulted in lower uptake and usage compared to the randomized controlled trial (RCT), with only 120 users enrolling and an average of 1.5 modules completed, compared to 3.7 in the RCT.

Despite lower engagement, open access users, who were more diverse and had higher baseline distress, reported greater improvements in distress and mental quality of life, suggesting that even limited use of the program can lead to significant benefits for a broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding My Way from clinical trial to open access dissemination: comparison of uptake, adherence, and psychosocial outcomes of an online program for cancer-related distress. Beatty, L., Kemp, E., Koczwara, B.[2022]

Supportive psycho-oncological interventions, such as education, individual psychotherapy, and group therapy, have been shown to effectively reduce symptoms like pain, anxiety, and depression in cancer patients, thereby improving their quality of life.

The review highlights the need for further research into how psychological factors can influence cancer progression and survival rates, suggesting that understanding these connections could enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psycho-oncologic interventions--critical review]. Larbig, W.[2006]

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