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Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

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ClinicalTrials.gov Identifier: NCT05297734
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : November 4, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Manali Indravadan Patel, Stanford University

Brief Summary:
This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

Condition or disease Intervention/treatment Phase
End of Life Cancer Other: Receive technology-based supportive cancer care Behavioral: Receive redesigned team-based supportive cancer care Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Greater intervention effects on health-related quality of life

SECONDARY OBJECTIVES:

I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice

OUTLINE: Sites are randomized to 1 of 2 arms.

ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2996 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Controlled Trial among 24 clinics
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Actual Study Start Date : June 24, 2022
Estimated Primary Completion Date : October 15, 2026
Estimated Study Completion Date : October 15, 2026


Arm Intervention/treatment
Active Comparator: Technology-based supportive cancer care
Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.
Other: Receive technology-based supportive cancer care
All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
Other Name: Technology-based SCC approach

Experimental: Redesigned team-based supportive cancer care
Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.
Behavioral: Receive redesigned team-based supportive cancer care
Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.
Other Name: Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach




Primary Outcome Measures :
  1. Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [ Time Frame: Change in health-related quality of life from baseline to 3 months ]
    Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.


Secondary Outcome Measures :
  1. Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [ Time Frame: Change in health-related quality of life from baseline to 6, and 12 months ]
    Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.

  2. Change in patient activation using the Patient Activation Measure (PAM-13). [ Time Frame: Change in patient activation from baseline to 3, 6, and 12 months ]
    Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months.

  3. Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42. [ Time Frame: Change in satisfaction with care from baseline to 3, 6, and 12 months ]
    Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months.

  4. Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD) [ Time Frame: Change in satisfaction with decision from baseline to 3, 6, and 12 months ]
    Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months.

  5. Palliative Care Use (Self-reported and Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6 and 12 months after patient enrollment.

  6. Hospice Care Use (Self-reported and Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after patient enrollment.

  7. Emergency Department Visits (Self-reported and Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.

  8. Hospitalization Visits (Self-reported and Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.

  9. Documentation of goals of care discussions (Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.

  10. Documentation of symptom discussions (Chart Review) [ Time Frame: 3, 6, and 12 months after patient enrollment ]
    Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy
  2. Patients must have the ability to understand and willingness to provide consent
  3. Participants must speak English or Spanish

Exclusion Criteria:

  1. Inability to consent to the study
  2. Plans to change oncologist within 12 months
  3. Employed by the practice site
  4. Patients who anticipate moving from the area within 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05297734


Contacts
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Contact: Manali I Patel, MD MPH MS 6507234000 manalip@stanford.edu

Locations
Show Show 17 study locations
Sponsors and Collaborators
Stanford University
Patient-Centered Outcomes Research Institute
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Responsible Party: Manali Indravadan Patel, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT05297734    
Other Study ID Numbers: 63646
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manali Indravadan Patel, Stanford University:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Pancreatic Neoplasms
Sarcoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Stomach Neoplasms
Glioblastoma
Rectal Neoplasms
Colonic Neoplasms
Esophageal Neoplasms
Breast Neoplasms
Carcinoma, Renal Cell
Skin Neoplasms
Small Cell Lung Carcinoma
Osteosarcoma
Myelodysplastic Syndromes
Disease Progression
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Urogenital Neoplasms
Carcinoma, Bronchogenic
Additional relevant MeSH terms:
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Death
Pathologic Processes