Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supportive Care Intervention-Pancreas (SCI-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885884
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Yael Schenker, MD, MAS, University of Pittsburgh

Brief Summary:
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Behavioral: Embedded Supportive Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
Study Start Date : July 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Behavioral: Embedded Supportive Care
No Intervention: Usual Care
Participants will receive standard oncology care from their oncology providers.



Primary Outcome Measures :
  1. trial feasibility [ Time Frame: up to 2 years ]
    We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.

  2. acceptability of intervention participation [ Time Frame: 3 months (+/- 3 weeks) from patient enrollment ]
    We will report the percentage of patients and caregivers who found the intervention acceptable.

  3. intervention fidelity [ Time Frame: Up to 2 years ]
    We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.

  4. perceived effectiveness [ Time Frame: 3 months (+/- 3 weeks) from patient enrollment ]
    We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.


Secondary Outcome Measures :
  1. change in patient quality of life [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). Because this is a pilot trial, we will not conduct formal tests of efficacy.

  2. patient healthcare utilization [ Time Frame: up to 2 years ]
    We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  3. patient quality of life [ Time Frame: 3 months (+/- 3 weeks) from patient enrollment ]
    We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.


Other Outcome Measures:
  1. patient illness understanding and care preferences [ Time Frame: 3 months (+/- 3 weeks) from patient enrollment ]
    We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  2. change in patient anxiety symptoms [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months. HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  3. change in patient distress [ Time Frame: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Scores will be compiled to assess range and distribution at 3-months. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  4. change in patient depressive symptoms [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  5. change in caregiver distress [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  6. change in caregiver burden [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  7. caregiver grief [ Time Frame: 1-3 months after death of enrolled patient ]
    We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up. We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data. Because this is a pilot study, we will not conduct formal tests of efficacy.

  8. change in caregiver anxiety symptoms [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  9. change in caregiver depressive symptoms [ Time Frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment ]
    We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  10. caregiver perceptions of circumstances surrounding death and preparedness for death [ Time Frame: 1-3 months after death of enrolled patient ]
    We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions. We will summarize range and distribution of responses. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  11. quality of life of seriously ill patients [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  12. patient emotional acceptance of illness [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  13. patient anxiety [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.

  14. patient distress [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Because this is a pilot trial, we will not conduct formal tests of efficacy.

  15. patient depression [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  16. caregiver distress [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  17. caregiver burden [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  18. caregiver anxiety symptoms [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.

  19. caregiver depressive symptoms [ Time Frame: 3 months (+/- 3 weeks) after enrollment ]
    We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients:

    • Adults (≥ 18 years old)
    • Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
    • Planning to receive continued care from an oncologist at the Hillman Cancer Center
    • Accompanied by a caregiver (family member or friend) at the first visit
  • Caregivers:

    • Adults (>= 18 years old)
    • Family member or friend of an eligible patient

Exclusion Criteria:

  • Patients:

    • Unable to read and respond to questions in English
    • Not planning to receive continued care from an oncologist at the Hillman Cancer Center
    • Pancreatic neuroendocrine cancer
  • Caregivers:

    • Unable to read and respond to questions in English

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): NCT01885884


Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Yael Schenker, MD, MAS University of Pittsburgh
Layout table for additonal information
Responsible Party: Yael Schenker, MD, MAS, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01885884    
Other Study ID Numbers: PRO13020507
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Yael Schenker, MD, MAS, University of Pittsburgh:
Supportive Care
Palliative Care
Pancreatic Cancer
Embedded, coordinated model of supportive care within oncology care
Patient and Caregiver support
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases