130 Participants Needed

Mental Health Support for Cancer

KM
CN
Overseen ByChristian Nelson, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat 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 data supports the effectiveness of the treatment Open Door for Cancer (OD-C) approach?

Research shows that supportive care interventions, like those involving feedback of patient-reported outcomes and management strategies, can improve anxiety, depression, and quality of life in cancer patients. Additionally, addressing mental health needs in cancer patients can enhance their engagement in treatment, leading to better overall outcomes.12345

How does the Open Door for Cancer (OD-C) treatment differ from other treatments for mental health support in cancer patients?

The Open Door for Cancer (OD-C) treatment is unique because it focuses on providing psychosocial support specifically tailored for cancer patients, addressing both mental disorders and distress that arise during cancer treatment. Unlike standard treatments, OD-C may incorporate elements from various psychosocial interventions to offer comprehensive support, although specific details about its components or approach are not provided in the available research.678910

Research Team

KM

Kelly McConnell, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.
See 9 more

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
See 2 more

Timeline

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

Treatment Details

Interventions

  • Open Door for Cancer (OD-C) approach
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Open Door for Cancer (OD-C)Experimental Treatment1 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 CareActive Control2 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

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
How to Reduce the No-Show Rate in the Psychiatric Oncology Clinic: Clinical Safety and Effectiveness Project.Rashid, A., Rickman, K., Saraykar, S.[2021]
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.
[Psychotherapy in cancer patients].Frick, E.[2007]

References

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. [2022]
How to Reduce the No-Show Rate in the Psychiatric Oncology Clinic: Clinical Safety and Effectiveness Project. [2021]
[Psychotherapy in cancer patients]. [2007]
A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope. [2019]
[Psycho-oncologic interventions--critical review]. [2006]
An inventory of psychosocial oncological interventions in The Netherlands: identifying availability, gaps, and overlap in care provision. [2021]
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. [2022]
[Cancer medicine in a state of flux - Where does psycho-oncology stand? : New challenges for cancer patients and treating physicians]. [2023]
Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients - study protocol of an epidemiological multi-center study. [2021]
Psychological Distress during Ovarian Cancer Treatment: Improving Quality by Examining Patient Problems and Advanced Practice Nursing Interventions. [2023]