Studies
| Study First Submitted Date | 2021-10-12 |
| Study First Posted Date | 2021-10-25 |
| Last Update Posted Date | 2023-06-05 |
| Start Month Year | June 1, 2024 |
| Primary Completion Month Year | September 1, 2029 |
| Verification Month Year | June 2023 |
| Verification Date | 2023-06-30 |
| Last Update Posted Date | 2023-06-05 |
Detailed Descriptions
| Sequence: | 20701697 |
| Description | The purpose of the study is to reduce rural-urban disparities and improve the quality of cancer care for these patients: (Aim 1): By using mixed methods, investigators will adapt the stepped collaborative care intervention to address the contextual needs of patients diagnosed with comorbid cancer and depression living in rural, low-income communities. Using face-to-face qualitative interviews with 30 patients diagnosed with cancer and quantitative data from our past trial, investigators will adapt the stepped collaborative care intervention for patients diagnosed with cancer from rural, low-income communities. For all quantitative data, 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. Thorough exploratory data analyses will be performed to ascertain data characteristics and to screen for anomalies (i.e., outliers). The preliminary exploration of the data will be used to: (1) examine univariate and bivariate distributions; (2) identify any imbalances between treatment groups on baseline characteristics; (3) investigate the magnitude of the associations between the dependent variables and the potential covariates; (4) determine the internal consistency reliabilities of the measurement scales using Cronbach's alpha; and (5) verify the statistical assumptions of the planned primary analyses. If assumptions are violated, then alternative procedures such as data transformations or more robust statistical methods will be considered. Missing data will be examined using available data on subject characteristics. Logistic regression models will be created with SAS PROC LOGISTIC to compare the characteristics of subjects who remained in the study versus those who dropped out. If data are determined to be missing at random, likelihood estimation procedures available in SAS PROC MIXED will produce unbiased estimates and allow the retention of subjects with missing data on outcomes. If data are determined to be not missing at random, pattern mixture or selection modeling will be used to investigate attrition. If necessary, multiple imputation (SAS PROC MI) will be used to impute missing values for covariates. (Aim 2): To test, in a randomized controlled trial, the adapted stepped collaborative care intervention for 242 patients diagnosed with comorbid cancer and depression living in rural, low-income communities. Primary hypotheses are that patients randomized to the stepped collaborative care intervention will report clinically meaningful (0.40 or greater effect size) improvements in depression and Quality of Life (QoL) at 6- and 12-months when compared to patients randomized to the screening and referral arm. The secondary hypotheses are that patients randomized to the stepped collaborative care intervention will report clinically meaningful (0.30 or greater effect size) improvements in sleep quality, perceived stress, and social support when compared to the screening and referral arm. The expectation is that caregivers of patients randomized to the intervention arm will have reductions in stress and depression when compared to caregivers of patients randomized to the screening and referral arm. Further exploration will be done of the beneficial effects of the stepped collaborative care intervention on survival. (Aim 3): To examine the cost-effectiveness of the stepped collaborative care intervention for 242 patients diagnosed with cancer and depression. The stepped collaborative care intervention is expected to be cost-effective compared to the screening and referral arm from the health system perspective in terms of cost per quality-adjusted life year based on established benchmarks for cost-effectiveness. Given the low cost of the intervention and our preliminary data showing reductions in complications and healthcare utilization, there is a high chance that the intervention is, on average, cost saving. (Aim 4): Guided by the Consolidated Framework for Implementation Science (CFIR), The acceptability, feasibility and actionable factors within the rural context that influence the delivery of the stepped collaborative care intervention will be assessed.. Using mixed methods, guided by the CFIR framework, Surveys will be administered and qualitative interviews performed with patients, caregivers, providers, clinical and research staff after testing the screening and adapted intervention to further refine and inform future implementation in rural, low-income communities. In terms of relevant prior knowledge and gaps in current knowledge, over 60 million people live in rural communities in the United States. Those who develop cancer are diagnosed later, at more advanced stages, with greater physical comorbidities, poorer quality of life (QoL), and have fewer options for treatment and resources to cope with a diagnosis of cancer when compared to those living in urban communities. As a result, they suffer from greater cancer-related distress and depression. Patients diagnosed with cancer from rural Appalachia were more likely to meet the criteria for clinical levels of distress compared to 27.4% of non-rural cancer patients. Investigators have also observed higher rates of depression in patients from rural, low-income areas when compared to their urban counterparts in Appalachia. Despite the high rates of depression, people who live in rural communities are 47% less likely to receive mental health treatment and 72% less likely to receive specialized mental health treatment when compared to those living in urban communities. Depression results in poorer QoL, decreased adherence to cancer treatments, and increased risk of mortality. Pharmacological and non-pharmacological treatments that have been effective in people from urban communities have not been effective in those living in rural, low-income communities. A stepped collaborative care intervention was designed and tested for socioeconomically disadvantaged patients with comorbid cancer and depression. While the intervention was effective for patients from urban, low-income communities, subgroup analyses revealed the intervention was not effective in patients from rural, low-income communities. While preliminary, there is the belief that cognitive-behavioral therapy (CBT) may not be culturally sensitive in rural, low-income patients. In addition, predictors of depression for these patients included poor sleep, high levels of perceived stress, and lack of social support. The proposal is to adapt the intervention using problem solving therapy, rather than CBT; provide resources to reduce financial stress; and incorporate stress management, support groups, and treatment of sleep problems in the novel intervention. In effort to reduce rural-urban disparities and improve the quality of cancer care, the objectives of this study will be to: (1) adapt the stepped collaborative care intervention to maximize effectiveness for rural, low-income patients, (2) test the effectiveness of the adapted intervention, and (3) prepare for implementation of the intervention in rural, low-income communities. |
Facilities
| Sequence: | 199844111 |
| Name | University of Pittsburgh Medical Centers |
| City | Pittsburgh |
| State | Pennsylvania |
| Zip | 15213 |
| Country | United States |
Facility Contacts
| Sequence: | 28079986 |
| Facility Id | 199844111 |
| Contact Type | primary |
| Name | Jennifer L Steel, PhD |
| steeljl@upmc.edu | |
| Phone | 412-692-2041 |
Conditions
| Sequence: | 52116536 | Sequence: | 52116537 | Sequence: | 52116538 | Sequence: | 52116539 | Sequence: | 52116540 |
| Name | Depression | Name | Quality of Life | Name | Social Support | Name | Sleep | Name | Stress |
| Downcase Name | depression | Downcase Name | quality of life | Downcase Name | social support | Downcase Name | sleep | Downcase Name | stress |
Id Information
| Sequence: | 40116515 |
| Id Source | org_study_id |
| Id Value | STUDY21060157 |
Countries
| Sequence: | 42520366 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55534434 | Sequence: | 55534435 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Stepped collaborative care intervention | Title | Enhanced Usual Care |
| Description | The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds. | Description | Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed. |
Interventions
| Sequence: | 52431486 | Sequence: | 52431487 |
| Intervention Type | Behavioral | Intervention Type | Behavioral |
| Name | Stepped collaborative care intervention | Name | Enhanced Usual Care |
| Description | Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional. | Description | Usual care from health providers |
Design Outcomes
| Sequence: | 177186914 | Sequence: | 177186915 | Sequence: | 177186916 | Sequence: | 177186917 | Sequence: | 177186918 | Sequence: | 177186919 | Sequence: | 177186920 | Sequence: | 177186921 | Sequence: | 177186922 | Sequence: | 177186923 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Center for Epidemiologic Studies Depression Scale (CES-D)F | Measure | Center for Epidemiologic Studies Depression Scale (CES-D) | Measure | EuroQOL-5 Dimension Questionnaire (EQ-5D) | Measure | EuroQOL-5 Dimension Questionnaire (EQ-5D) | Measure | Interpersonal Support Evaluation List (ISEL) | Measure | Interpersonal Support Evaluation List (ISEL) | Measure | Pittsburgh Sleep Quality Index (PSQI) | Measure | Pittsburgh Sleep Quality Index (PSQI) | Measure | Perceived Stress Scale (PSS) | Measure | Perceived Stress Scale (PSS) |
| Time Frame | Change from baseline in depression at 6 months | Time Frame | Change from baseline in depression at 12 months | Time Frame | Change from baseline in quality of life at 6 months | Time Frame | Change from baseline in quality of life at 12 months | Time Frame | Change from baseline of interpersonal support evaluation at 6 months | Time Frame | Change from baseline of interpersonal support evaluation at 12 months | Time Frame | Change from baseline in improved sleep latency at 6 months. | Time Frame | Change from baseline in improved sleep latency at 12 months. | Time Frame | Change from baseline in perceived stress at 6 months | Time Frame | Change from baseline in perceived stress at 12 months |
| Description | Measure of depression questionnaire- The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed. | Description | Measure of depression questionnaire – The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed. | Description | Measure of quality of life questionnaire – scale is numbered from 0 to 100. 100 means the best health the participant can imagine. 0 means the worst health the participant can imagine. | Description | Measure of quality of life questionnaire – scale is numbered from 0 to 100. 100 means the best health the participant can imagine. 0 means the worst health the participant can imagine. | Description | A 12-item measure of perceptions for three dimensions of perceived social support.(Appraisal Support, Belonging Support, Tangible Support) Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". | Description | A 12-item measure of perceptions for three dimensions of perceived social support.(Appraisal Support, Belonging Support, Tangible Support) Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". | Description | A measure of sleep quality where respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. | Description | A measure of sleep quality where respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. | Description | This questionnaire about stress is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. Individuals rate items on a 5-point Likert scale, ranging from 0 – "Never" to 4 – "Very often." Scores range from 0-56, with higher scores indicating greater perceived stress. | Description | This questionnaire about stress is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. Individuals rate items on a 5-point Likert scale, ranging from 0 – "Never" to 4 – "Very often." Scores range from 0-56, with higher scores indicating greater perceived stress. |
Browse Conditions
| Sequence: | 193274350 | Sequence: | 193274351 |
| Mesh Term | Depression | Mesh Term | Behavioral Symptoms |
| Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48269691 | Sequence: | 48269692 |
| Agency Class | OTHER | Agency Class | NIH |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | University of Pittsburgh | Name | National Cancer Institute (NCI) |
Overall Officials
| Sequence: | 29254523 |
| Role | Principal Investigator |
| Name | Jennifer L Steel, PhD |
| Affiliation | UPMC Department of Surgery |
Central Contacts
| Sequence: | 11996755 | Sequence: | 11996756 |
| Contact Type | primary | Contact Type | backup |
| Name | Jennifer L Steel, PhD | Name | Jennifer L Steel, PhD |
| Phone | 412-692-2041 | Phone | 14126922041 |
| steeljl@upmc.edu | steeljl@upmc.edu | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68076936 | Sequence: | 68076937 |
| Design Group Id | 55534434 | Design Group Id | 55534435 |
| Intervention Id | 52431486 | Intervention Id | 52431487 |
Eligibilities
| Sequence: | 30734568 |
| Gender | All |
| Minimum Age | 21 Years |
| Maximum Age | 100 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Patients: biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age >21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported. Caregivers: a spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the UPMC's Liver Cancer Center; and age >21 years Exclusion Criteria: Patients: age < 21 years, lack of fluency in English, evidence of thought disorder, delusions, hallucinations, or suicidal ideation. Caregivers: lack of fluency in English; and evidence of thought disorder, delusions, hallucinations, or suicidal ideation. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254010477 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 21 |
| Maximum Age Num | 100 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 4 |
| Number Of Secondary Outcomes To Measure | 6 |
Designs
| Sequence: | 30480936 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Supportive Care |
| Time Perspective | |
| Masking | Single |
| Masking Description | Research Study Coordinators will be masked. |
| Intervention Model Description | Randomized controlled trial |
| Outcomes Assessor Masked | True |
Intervention Other Names
| Sequence: | 26642188 | Sequence: | 26642189 |
| Intervention Id | 52431486 | Intervention Id | 52431487 |
| Name | Treatment | Name | Control |
Responsible Parties
| Sequence: | 28847289 |
| Responsible Party Type | Principal Investigator |
| Name | Jennifer Steel |
| Title | Professor |
| Affiliation | University of Pittsburgh |
Ipd Information Types
| Sequence: | 3330363 | Sequence: | 3330364 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |