Psychiatric–Medical ComorbidityThe Indiana Cancer Pain and Depression (INCPAD) trial: Design of a telecare management intervention for cancer-related symptoms and baseline characteristics of study participants
Introduction
Pain and depression are two of the most common treatable symptoms in cancer patients yet often remain undetected and/or inadequately treated. Pain is present in 14–100% of cancer patients, depending on the setting, and the prevalence of major depressive disorder is 10–25%, with a similar range for clinically depressive symptoms [1], [2], [3], [4]. The impact of these symptoms on functional status and quality of life is considerable [5], [6], [7], [8], [9], [10]. Depression is frequently underdiagnosed in cancer patients [11], [12], [13], and up to half of cancer patients depressed at baseline remain depressed at the 1-year follow-up [1]. Likewise, cancer pain often is undertreated [1], [14], [15].
Four common barriers to effective treatment of symptoms in both primary and specialty care are underdetection of bothersome symptoms, inadequate initial treatment, failure to monitor adherence and response and failure to adjust therapy in nonresponding patients [16]. These are well established for depression as well as pain and other symptoms [17], [18], [19], [20], [21], [22], [23], [24], [25]. These four barriers are also among the most common and “action-able” in oncology [26], [27], [28], [29], [30]. In primary care, much has been written about the concept of “competing demands” in time-limited visits [31], [32]. Clearly, this pertains to oncology practice as well, in which the time required for evaluation and treatment of the primary cancer competes with time left over for such associated symptoms as pain and depression. Understandably, the nuances of antidepressants and various pain regimens as well as subsequent symptom monitoring may be outweighed by the requisite attention to chemotherapy, tumor response, hematological nadirs and other complexities of cancer treatment.
Multicomponent-system interventions consistently improve depression outcomes, whereas single-component interventions, such as depression screening and provider education, are insufficient by themselves [17], [18], [33], [34]. Indeed, the U.S. Preventive Services Task Force recommends depression screening only if there are adequate systems in place to support depression treatment and monitoring [35]. A review of 28 randomized multicomponent effectiveness trials for treatment of depression in primary care demonstrated a median absolute increase of 18.4% in the proportion of patients achieving a 50% improvement [36]. Disease management programs have also been proven to be beneficial for diabetes, heart failure, asthma and other chronic medical disorders [37]. However, the effectiveness of collaborative care and/or disease management programs for pain has not been established, and the generalizability of studies largely conducted in primary care to the more specialized setting of oncology practices is not known.
Numerous clinical trials have established the effectiveness of telephone care management and telepsychiatry for depression treatment in primary care patients across a variety of settings, ranging from large organized health care systems to more rural settings [38], [39], [40], [41], [42]. Indeed, their benefits compared with usual care may even be greater in rural settings [43]. Preliminary data in cancer trials also suggest the potential effectiveness of telemedicine for pain management [44].
Although simple telephone-based screening for depression in oncology practices has been proven to be acceptable [45], telecare management of depressed cancer patients has not been studied. The promising studies in cancer patients with depression, pain and/or fatigue by Given et al. [44], [46], [47] differ from our trial in that (a) their interventions were psychoeducational rather than pharmacological (which affects generalizability since medications are more commonly the initial approach for pain and depression in oncology practices); (b) the number of required nursing contacts (9–10) was higher, and half were in-person visits; and (c) some of the outcomes were of marginal significance due to a much smaller sample size.
Fig. 1 illustrates the three-component model (TCM) developed for the treatment of depression in medical settings [48] and empirically validated in a dissemination depression trial involving 60 primary care practices [49], [50]. TCM is based on relationships between three types of providers collaborating through complementary roles in overcoming barriers to optimal disease management. The three providers are the patient's primary provider, a nurse care manager and a specialty consultant. The Indiana Cancer Pain and Depression (INCPAD) trial comprises an oncology practice (often consisting of an intrapractice oncologist–nurse partnership), a depression–pain care manager (DPCM) and a psychiatrist with special expertise in pain management. The relationships are illustrated in Fig. 1, reflecting the central role of the DPCM as the key liaison between the patient, oncology practitioner and psychiatrist. The four cardinal barriers addressed by the TCM are failures in symptom detection (in this case, pain and depression), treatment initiation, monitoring of symptom response as well as adherence to and adverse effects of treatment and adjustment of therapy in patients not responding to or intolerant of initial treatment. The primary roles are as follows: (a) the oncology practitioner — either physician or nurse — detects bothersome symptoms (e.g., pain and depression screening complemented by spontaneous patient reporting and provider inquiry); (b) the DPCM recommends treatment for symptoms in accordance with evidence-based guidelines and monitors response and adherence; and (c) the psychiatrist supervises the DPCM and advises on complex or nonresponding cases. The oncologist implements treatment recommendations, and the psychiatrist becomes directly involved in the management of difficult cases (telephone or in-person patient consultation).
Section snippets
Overall design
Following an eligibility interview and ascertainment of informed consent, patients are randomized to the TCM intervention arm or the usual-care control arm. The intervention consists of automated home-based symptom monitoring coupled with centralized telephonic care management. Outcome assessments are conducted at baseline and at 1, 3, 6 and 12 months by interviewers blinded to treatment arms. The two primary outcomes are depression severity (assessed by the SCL-20) and pain
Summary
The INCPAD trial has been successful in enrolling 405 cancer patients from 16 urban and rural oncology clinics, the majority of which are community based. Many eligible patients did not enroll because of lack of interest, poor health due to their cancer or other comorbid medical illnesses, they were feeling too well or too busy, problems with a telephone-based intervention or family factors. Barriers to enrollment in cancer symptom research have been recently reviewed [114].
In summary, the
Acknowledgment
This study was supported by a grant from the National Cancer Institute to Dr. Kroenke (R01 CA-115369).
References (114)
- et al.
An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain
Pain
(1999) - et al.
Management of cancer pain
Lancet
(1999) - et al.
Predictors of pain and fatigue in the year following diagnosis among elderly cancer patients
J Pain Symptom Manage
(2001) - et al.
Interventions to improve provider diagnosis and treatment of mental disorders in primary care: a critical review of the literature
Psychosomatics
(2000) - et al.
Barriers to effective cancer pain management: a review of the literature
J Pain Symptom Manage
(1999) - et al.
Putting cancer pain management regimens into practice at home
J Pain Symptom Manage
(2002) Competing demands in psychosocial care: a model for the identification and treatment of depressive disorders in primary care
Gen Hosp Psychiatry
(1997)- et al.
Systematic review of multifaceted interventions to improve depression care
Gen Hosp Psychiatry
(2007) - et al.
Diagnosing major depression in medical outpatients: acceptability of telephone interviews
J Psychosom Res
(2003) - et al.
A three-component model for reengineering systems for the treatment of depression in primary care
Psychosomatics
(2002)
Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study design and practical implications of an intervention for comorbid pain and depression
Gen Hosp Psychiatry
Detecting panic disorder in medical and psychosomatic outpatients — comparative validation of the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire, a screening question, and physicians' diagnosis
J Psychosom Res
Physical symptom disorder: a simpler diagnostic category for somatization-spectrum conditions
J Psychosom Res
The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress
Eur J Cancer
Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9)
J Affect Disord
Implementing national standards for cancer pain management: program model and evaluation
J Pain Symptom Manage
Management of cancer symptoms: pain, depression, and fatigue. Evidence Report/Technology Assessment No. 61 (prepared by the New England Medical Center Evidence-Based Practice Center under contract no. 290-97-0019)
Depression in cancer patients: a literature review
Eur J Cancer Care
The impact of age, treatment, and symptoms on the physical and mental health of cancer patients. A longitudinal perspective
Cancer
Predictors of depressive symptomatology of geriatric patients with colorectal cancer: a longitudinal view
Support Care Cancer
Physical functioning and depression among older persons with cancer
Cancer Pract
The influence of symptoms, age, comorbidity and cancer site on physical functioning and mental health of geriatric women patients
Women Health
Depression and functional status as predictors of death among cancer patients
Cancer
Psychiatric morbidity and its recognition by doctors in patients with cancer
Br J Cancer
Oncologists' recognition of depression in their patients with cancer
J Clin Oncol
Major depression in outpatients attending a regional cancer centre: screening and unmet treatment needs
Br J Cancer
Pain and its treatment in outpatients with metastatic cancer
N Engl J Med
Undertreatment of cancer pain in elderly patients
JAMA
Improving primary care for patients with chronic illness: the chronic care model, Part 2
JAMA
Educational and organizational interventions to improve the management of depression in primary care: a systematic review
JAMA
Improving outcomes in depression
BMJ
Understanding team-based quality improvement for depression in primary care
Health Serv Res
Pain assessment and management: an organizational approach
Pain management: Part 1. Overview of physiology, assessment, and treatment
The management of persistent pain in older persons
J Am Geriatr Soc
Quality indicators for pain management in vulnerable elders
Ann Intern Med
Systematic review of outpatient services for chronic pain control
Health Technol Assess
Pain management: Part 4. Cancer pain and end-of-life care
Lack of adherence with the analgesic regimen: a significant barrier to effective cancer pain management
J Clin Oncol
Implementing guidelines for cancer pain management: results of a randomized controlled clinical trial
J Clin Oncol
Competing demands: does care for depression fit in primary care?
J Gen Intern Med
Effectiveness of disease management programs in depression: a systematic review
Am J Psychiatry
Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes
Arch Intern Med
Screening for depression in adults: a summary of the evidence for the U.S. Preventive Services Task Force
Ann Intern Med
Disease management and the organization of physician practice
JAMA
The telephone as a new weapon in the battle against depression
Eff Clin Pract
Efficacy of nurse telehealth care and peer support in augmenting treatment of depression in primary care
Arch Fam Med
Randomised trial of monitoring, feedback, and management of care by telephone to improve treatment of depression in primary care
BMJ
Treatment outcomes in depression: comparison of remote treatment through telepsychiatry to in-person treatment
Am J Psychiatry
Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial
JAMA
Cited by (61)
Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer
2020, Contemporary Clinical TrialsPredictors of depression outcomes in adults with cancer: A 12 month longitudinal study
2020, Journal of Psychosomatic ResearchMinimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials
2020, Journal of Affective DisordersThe rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions
2018, Contemporary Clinical TrialsCitation Excerpt :Pain management in the trial's Arm III mirrored that of the telecare approach validated in the INCPAD trial [6]. More specifically, telephone-based pain management was delivered by a nurse PCM trained in assessing treatment responses with standardized pain scales; evaluating medication adherence; providing brief pain-specific patient education; and in forwarding adjustments according to evidence-based cancer pain treatment guidelines to the participant's care team [9,38]. The PCM contacted Arm III participants, see Table 1, during week 1 to describe their role and to determine whether pain was an impediment to their performance of REST or the FSP.