Behaviors and Mental Disorders

All Conditions

Depressive Disorder

Depression

Behavioral Symptoms

Quality of Life

Referred to a therapist and/or psychiatrist in their home town depending on the type of treatment they prefer (e.g., behavioral and/or medication)

At least biweekly contact from a care coordinator by phone and face-to- face visits occurring approximately every 2 months during the patients outpatient visits or treatment, and 24/7 access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.

enhanced usual care

Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional

stepped collaborative care

Jennifer L. Steel, PhD

The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers. Biobehavioral factors will include assessment of changes in health behaviors and biomarkers of inflammation. The investigators will also include measures metabolic abnormalities and clinical markers of CVD. The investigators expect few cardiac events during the study period. The investigators will also measure other health outcomes but CVD risk factors will be the focus of the study.

The investigators expect to follow the caregivers for 12 months during the caregiving period.

Based on our prior experience and that of others, patients with clinical levels of symptoms report the greatest benefit from interventions aimed at reducing depressive symptoms. The investigators will screen caregivers for clinical levels of depression using the CES-D scale. If the caregiver screens positive for clinical levels of depressive symptoms (CES-D\>16) and the patients and caregiver consent to participation, the dyad will be randomized to the intervention or enhanced usual care arm based on block randomization and stratification by gender (male/female) to assure approximate equal gender distribution in each arm of the study. The screening will take place in UPMC Montefiore and Presbyian.

The participants of this study will be blinded to which arm of the intervention they received, either the stepped collaborative care or enhanced usual care. Prior to randomization they will be asked to provide information on the intervention that they prefer and at the end of the intervention they will be asked what intervention they think they received. The findings will be analyzed to determine if intervention preference or perception of intervention received affected the outcomes.

The care coordinators for the proposed intervention will have Master's degrees in psychology or counseling and training in cognitive-behavioral therapy and have experience working with people diagnosed with cancer and their families. The care coordinators will receive training at the University of Pittsburgh in cultural competence. The therapists will serve as a liaison between the patient and other health care professionals within the spousal and intimate partner caregivers' medical team. A psychiatrist will not be included as part of the study team as many of the spousal and intimate partner caregivers do not reside locally. The care coordinator will work with the spousal and intimate partner caregivers' PCP, psychiatrist, and other health care providers in the spousal and intimate partner caregivers' home community to manage the symptoms and medication if indicated. The care coordinators will be supervised by the PI who is a clinical psychologist who has been working with cancer patients and their caregivers for 20 years.

Patient and caregiver outcomes will be assessed using a battery of standardized questionnaires. The investigators have chosen instruments that are as brief as possible to limit burden to patient and spousal and intimate partner caregivers. All instruments have been demonstrated to be valid and reliable. The order of the instruments in the battery of questionnaires will begin with general, not emotionally laden instruments and also end with instruments which may not increase distress in a participant. The proposed time points (baseline, 4, 8, and 12 months) reflect intervals that permit the ability to capture changes in symptoms and inflammatory biomarkers while not burdening the patient or spousal/intimate partner caregivers. The proposed questionnaires were used in prior studies by this team and with advanced cancer patients and their family caregivers. The investigators have shown better adherence to completing the outcomes measures with self-reported pencil and paper questionnaires versus telephone interviews (K07CA118576; R01CA176809). However, the investigators will also offer telephone interviews for spousal and intimate partner caregivers or patients who have low levels of literacy, sensory impairments, or prefer a telephone interview. For all interviews, the research associate will be blinded to the participant's assigned treatment arm to prevent bias. The investigators have found no differences by method of administration (paper and pencil versus telephone interview). Inter-operator variability will be addressed by ensuring that the research staff performing measurement of blood pressure, and waist circumference will be trained together, tested by the PI for inter-operator consistency, and be assessed at intervals every 4 months for continued consistency in measurement of blood pressure and abdominal girth. Consistency in laboratory personnel techniques (inter operator variability) will be monitored by Dr. Butterfield.

The frequency distributions of study variables will be examined prior to statistical analyses to provide descriptive data and to identify departures from normality. If nonlinearity is detected, a transformation will be performed using the Box-Cox transformation, which finds the optimal relationship between variables. All measures have established reliability and validity similar to that from which the study sample will be drawn; however, the reliabilities of scales will be assessed using Cronbach's α.

Data will be analyzed using SAS (Version 9.3, SAS Institute, Inc., Cary, NC) to conduct preliminary exploratory analyses, missing data testing, and the analyses for the primary aims (linear mixed models). The level of significance for the analyses will be set at .05. The efficacy of the web-based stepped collaborative care intervention compared to enhanced usual care will be examined using the 'intent to treat' (ITT) approach, as well as the actual treatment received. In the ITT approach, subjects will be included in the analyses in the groups to which they were randomly assigned, regardless of treatment, adherence, withdrawal or deviation from protocol. The ITT approach minimizes the introduction of bias into the analyses and most closely aligns with clinical practice; therefore, it is strongly recommended for studies examining intervention efficacy.

Collaborative Care Intervention for Cancer Caregivers

University of Pittsburgh

Associate Professor of Surgery

The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up.

The patient in the patient only intervention arm will receive 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up

The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Dyadic Intervention. The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.

Dyadic Intervention

The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Patient Only Intervention. The patient in the Patient Only Intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.

Patient Only Intervention

Jennifer L Steel, PhD

The purpose of the study is to design and test a dyadic sleep intervention for patients diagnosed with cancer and their intimate partner.

Sleep problems remain underdiagnosed and undertreated among cancer patients despite their high prevalence and consequences to quality of life and health. Hepatobiliary cancer patients have one of the highest rates of sleep problems with 59% reporting poor sleep quality and 43% reporting sleeping less than 6 hours per night. Sleep problems were found to be associated with clinical levels of depressive symptoms, elevations in pain and fatigue. Investigators have observed that short sleep duration was associated with increased risk of mortality in patients with hepatobiliary cancers. Inflammation has been hypothesized to mediate the link between sleep and mortality. In hepatobiliary cancer, short sleep duration was associated with elevations in Interleukin (IL)-6, IL-1, IL-1 and IL-2 and poor sleep quality with elevations in Interferon (IFN) Interleukin-2, after adjusting for tumor associated inflammation, mediated the link between sleep duration and survival. These pro-inflammatory cytokines are also related to tumor growth and development of metastases. Sleep problems of spouses or intimate partners of hepatobiliary cancer patients were also prevalent with 62% reporting poor sleep quality and 33% reporting sleep less than 6 hours per night. Caregiving for an intimate partner with cancer has been linked to increased mortality and sleep has been proposed as a possible mediator of this link. Face to face cognitive behavioral therapy (CBT) has been shown to be effective in cancer patients and cancer caregivers. However, due to the distance patients travel to our medical center (58% \>1 hour), infrequency of visits (e.g., approximately every two months), limited resources (48% of patients \<$20,000 annual income), and the unpredictability of cancer-related symptoms; weekly face-to- face CBT to treat sleep problems is not feasible. Therefore, investigators will test a dyadic Modified Cognitive Behavioral Therapy for Insomnia (CBTi) intervention to reduce insomnia in patients and possibly caregivers and expect the findings of this study to have a significant public health impact for the over 12 million cancer patients and spousal/partner caregivers in which nearly half are estimated to suffer from sleep problems.

Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study

A Sleep Intervention for Cancer Patients and Their Caregivers

De-Identified Data may be shared with investigators who request data from the Primary Investigator

Reduction of Depressive Symptoms by 25%- total score ranging from 20-80, where lower scores indicate better quality of life

Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)

Improved Sleep Latency by 25% - Global Score ranging from 0 to 21, where lower score indicates better quality of sleep

Increase in Quality of Life by 25% - total score ranging from 20-80, where lower scores indicate better quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collaborative Care Intervention for Cancer Caregivers	NCT02944136	Depression Advanced Cancer	enhanced usual ... stepped collabo...	21 Years -	University of Pittsburgh
Collaborative Care Intervention for Cancer Caregivers	NCT02944136	Depression Advanced Cancer	enhanced usual ... stepped collabo...	21 Years -	University of Pittsburgh
A Sleep Intervention for Cancer Patients and Their Caregivers	NCT04969146	Intervention Control	Dyadic Interven... Patient Only In...	21 Years -	University of Pittsburgh
A Sleep Intervention for Cancer Patients and Their Caregivers	NCT04969146	Intervention Control	Dyadic Interven... Patient Only In...	21 Years -	University of Pittsburgh
A Sleep Intervention for Cancer Patients and Their Caregivers	NCT04969146	Intervention Control	Dyadic Interven... Patient Only In...	21 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for dyadic function