Mental Health Support for Cancer
Recruiting in Palo Alto (17 mi)
Overseen byKelly McConnell, PhD
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Severe cognitive impairment, Hospice care, Current mental health treatment, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
678910Eligibility 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.
+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
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
Weill Medical College of Cornell UniversityCollaborator
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]Patients with cancer experience considerable symptom burden, psychological morbidity, and unmet psychosocial needs. Research suggests that feedback of patient-reported outcomes to clinicians or caseworkers, alongside management strategies, may result in improved patient functioning. Two intervention models were developed to test this effect in a randomized, controlled trial against usual care (UC): a telephone caseworker (TCW) model and an oncologist/general practitioner (O/GP) model. Primary end points included anxiety, depression, physical/emotional functioning, and unmet supportive care needs.
How to Reduce the No-Show Rate in the Psychiatric Oncology Clinic: Clinical Safety and Effectiveness Project. [2021]Mental health stability among patients with cancer improves adherence to oncology treatment, contributing to better outcomes. In a comprehensive cancer center, the no-show rate for the psychiatric oncology clinic was higher than that of any other clinic at the center. A quality improvement project was designed to enhance patients' engagement in their mental health visits to emotionally equip them for their oncology treatments. Five months of data were reviewed, and strategies were implemented to remove barriers to attendance. These efforts markedly reduced the no-show rate. Addressing barriers to mental health care improved attendance at the mental health clinic.
[Psychotherapy in cancer patients]. [2007]The indication for complementary psychotherapy in cancer patients must be considered when the stresses of the disease and its treatment are more than the patient's reserves can cope with. The aims of psycho-oncological treatment include improvement of the patient's quality of life, management of comorbid psychological disorders, optimization of the patient's ability to cope, the provision of social support, the overcoming of feelings of helplessness and hopelessness, conflict- and focus-oriented stabilization, and prolongation of life. Since available psycho-oncological resources continue to be extremely thin on the ground, sound concepts must be developed with the aim of achieving a link-up of psycho-oncological resources with oncological services.
A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope. [2019]Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer.
[Psycho-oncologic interventions--critical review]. [2006]Following information on diagnosis, therapy and prognosis, supportive psycho-oncological interventions may be performed. General targets of psychological intervention are to help coping with disease problems and family-related problems and to reduce symptoms related to disease and therapy such as pain, anticipatory nausea and vomiting, stress, anxiety, depression and feeling of helplessness. A number of different kinds of controlled interventions may contribute significantly to both psychological and physical health outcomes in cancer patients. This review confirms the efficacy of education, individual psychotherapy, group interventions and behavioural training in reducing disease- related and therapy-related symptoms, depression and anxiety, thus improving psychological functioning and the quality of life. The multidimensional evaluation of psychooncological interventions including immunological parameters, the question of differential indication of psychological interventions in cancer patients' and the influence of psychological predictors on the course of different cancer diseases and survival rates are significant aspects that merit further research.
An inventory of psychosocial oncological interventions in The Netherlands: identifying availability, gaps, and overlap in care provision. [2021]Purpose: While a wide range of psychosocial oncological (PO) interventions has been developed, a systematic overview of interventions to inform patients, care providers, as well as researchers, policy makers and health insurers, is lacking. The aims of this paper were (1) to describe the attainment of this overview, which may be used in other jurisdictions and for other health conditions and (2) to reflect on what determines developments in this field.Methods: Dutch researchers and care providers were invited to describe PO-interventions they apply in research or clinical practice. Selection criteria for what constituted a PO-intervention were determined. The input was organized in 12 predefined categories (e.g. physical functioning, genetics).Findings: Sixty-six PO-interventions were included in the overview. Two major categories were psychosocial functioning (24%) and physical functioning and recovery (24%). Interventions are mostly directed at adults (65%) and not aimed at a specific type of cancer (61%). Nearly 25% of the interventions lacked scientific underpinning.Conclusions: This paper provides an overview of Dutch PO-interventions and input on what drives their development. The categorizing method can be used in other jurisdictions and for other health care conditions. A next step would be to investigate the effectiveness and evidence of PO-interventions.Implications for Psychosocial Providers and Policy: The open access overview of interventions provides referral information for care providers. By identifying possible gaps and overlap, the overview looks at possible drivers behind developments in this field which will be of interest to policy makers.
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]Few digital psycho-oncology programs have been adopted into routine practice; how these programs are used after trial completion remains unexplored. To address this, the present study transitioned our evidence-based 6-module CBT-based program, Finding My Way, into open access (OA) after completion of the RCT, and compared uptake, usage, and psychosocial outcomes to the earlier RCT.
[Cancer medicine in a state of flux - Where does psycho-oncology stand? : New challenges for cancer patients and treating physicians]. [2023]Despite significantly improved supportive measures, oncological treatment is still exhausting and is accompanied by organ loss, disability and functional limitations. In the longer term those affected have to cope with the loss of important life commodities and after the end of treatment to live under the much-cited "sword of Damocles". Around one third of all people diagnosed with cancer develop a mental disorder at some point during the course of the illness that requires treatment and pronounced stress reactions occur at key points over the course of treatment. Both mental disorders and subsyndromic distress can be successfully treated with psychotherapeutic and psycho-oncological interventions. Therefore, every cancer patient should be informed about the availability and potential benefit of psycho-oncological support after the diagnosis or in the further course of treatment.
Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients - study protocol of an epidemiological multi-center study. [2021]Empirical studies investigating the prevalence of mental disorders and psychological distress in cancer patients have gained increasing importance during recent years, particularly with the objective to develop and implement psychosocial interventions within the cancer care system. Primary purpose of this epidemiological cross-sectional multi-center study is to detect the 4-week-, 12-month-, and lifetime prevalence rates of comorbid mental disorders and to further assess psychological distress and psychosocial support needs in cancer patients across all major tumor entities within the in- and outpatient oncological health care and rehabilitation settings in Germany.
Psychological Distress during Ovarian Cancer Treatment: Improving Quality by Examining Patient Problems and Advanced Practice Nursing Interventions. [2023]Background/Significance. Ovarian cancer patients are prone to psychological distress. The clinical significance and best practices for distress among this population are poorly understood. Method. Secondary analysis of research records from a six month randomized control trial included 32 women with primary ovarian cancer. All received 18 advanced practice nurse (APN) visits over six months. Three sub-samples were determined by distress level (high/low) and mental health service consent for high distress. Demographic, clinical factors, patient problems and APN interventions obtained through content analysis and categorized via the Omaha System were compared. Results. Clinically-significant psychiatric conditions were identified in 8/18 (44%) high distress subjects consenting to mental health intervention. High distress subjects who refused mental health intervention had more income and housing problems than the other subjects, received the fewest interventions at baseline, and progressively more throughout the study, exceeding the other sub-samples by study completion. Conclusions. Highly-distressed women not psychologically ready to work through emotional consequences of cancer at treatment onset may obtain support from APNs to manage cancer problems as they arise. Additional studies may identify best practices for all highly-distressed women with cancer, particularly those who do not accept mental health services for distress, but suffer from its effects.