Intervention for Rural Cancer Patients

Depression Clinical Trial

Official title:

A Hybrid Type I Randomized Effectiveness-Implementation Trial of Remote Treatment of Depression in Rural Community Cancer Centers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05091593
• Other study ID #: STUDY21060157
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: December 1, 2031

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Jennifer L Steel, PhD
• Phone: 412-692-2041
• Email: steeljl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In an effort to reduce rural-urban disparities and improve the quality of cancer care for these patients, the objectives of this study will be to: (1) adapt the 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 512
• Est. completion date: December 1, 2031
• Est. primary completion date: September 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Quality of Life
• Sleep
• Social Support
• Stress

Intervention

Behavioral:
• Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional.
• Enhanced Usual Care
Usual care from health providers

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Centers	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiologic Studies Depression Scale (CES-D)F	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.	Change from baseline in depression at 6 months
Primary	Center for Epidemiologic Studies Depression Scale (CES-D)	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.	Change from baseline in depression at 12 months
Primary	EuroQOL-5 Dimension Questionnaire (EQ-5D)	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.	Change from baseline in quality of life at 6 months
Primary	EuroQOL-5 Dimension Questionnaire (EQ-5D)	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.	Change from baseline in quality of life at 12 months
Secondary	Interpersonal Support Evaluation List (ISEL)	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".	Change from baseline of interpersonal support evaluation at 6 months
Secondary	Interpersonal Support Evaluation List (ISEL)	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".	Change from baseline of interpersonal support evaluation at 12 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	Change from baseline in improved sleep latency at 6 months.
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	Change from baseline in improved sleep latency at 12 months.
Secondary	Perceived Stress Scale (PSS)	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.	Change from baseline in perceived stress at 6 months
Secondary	Perceived Stress Scale (PSS)	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.	Change from baseline in perceived stress at 12 months