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A Study of Mental Health Care in People With Cancer

ConditionsBreast CancerColorectal CancerLung CancerProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMemorial Sloan Kettering Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Per medical record and/or self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older

Per medical record and/or self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment

Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)

How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)

Disqualifiers

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

Per research staff judgment and/or self-report, too ill or weak to complete study procedures

Per medical record and/or self-report, receiving hospice care at the time of enrollment

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Questionnaires

    Other intervention

    Patient demographic characteristics, Clinical variables, Cornell Service Index-Short Form (CSI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale-7 (GAD-7), Client Satisfaction Questionnaire (CSQ-8), Intention to Seek Help Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Severity Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Benefits Scale, Barriers to Mental Health Services Scale-Revised, Cues to action, Self-Efficacy to Seek Mental Health Care (SE-SMHC)

  • Interviews

    Other intervention

    Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.

  • 30-minute telephone or videoconference sessions

    Other intervention

    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. The five components are: 1. Provide education about depression and treatment options 2. Identify treatment preferences and a personal goal achievable with mental health care 3. Assess barriers to treatment initiation 4. Recommend a referral using standardized referral options 5. Address barriers to accessing care

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Open Door for Cancer (OD-C)Experimental treatment 1 intervention
Group B: Usual CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Refusal rates

≥75% of eligible patients enroll in the study

Time frame
2 years
2

Attrition rates

≥80% of patients who enroll complete all study procedures

Time frame
2 years

Secondary outcomes

1

Treatment satisfaction

Client Satisfaction Questionnaire-8 mean score of ≥3

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Weill Medical College of Cornell University

Collaborator

Source ClinicalTrials.gov
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