Intervention for Rural Cancer Patients

NCT05091593 | Withdrawn DMC

• 1 other identifier: STUDY21060157
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Interpersonal Support Evaluation List (ISEL)

  Change from baseline of interpersonal support evaluation at 6 months

• Interpersonal Support Evaluation List (ISEL)

  Change from baseline of interpersonal support evaluation at 12 months

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in improved sleep latency at 6 months.

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in improved sleep latency at 12 months.

• Perceived Stress Scale (PSS)

  Change from baseline in perceived stress at 6 months

Study Arms (2)

Stepped collaborative care intervention

EXPERIMENTAL

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.

Behavioral: Stepped collaborative care intervention

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

Stepped collaborative care intervention BEHAVIORAL

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

Also known as: Treatment

Stepped collaborative care intervention

Enhanced Usual Care BEHAVIORAL

Usual care from health providers

Also known as: Control

Enhanced Usual Care

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Medical Centers

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer L Steel, PhD

  UPMC Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Study Coordinators will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified data will become available at the end of the study for up to one year following study completion.
• Access Criteria: Appropriate investigator credentials (MD, PhD) and direct request for up to one year following study completion

Locations

US (1)