Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices (Caregivers)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03746314
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Medical University of South Carolina
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this study is to understand current practices for engaging with informal (unpaid) caregivers of patients with cancer, characterize the availability of supportive care services, and assess the perspectives of multi-disciplinary oncology health care providers regarding identifying and supporting caregivers.

Condition or disease
Supportive Care

Detailed Description:

The primary goals of this study are to: 1) estimate the prevalence of: a) caregiver identification practices, b) psychosocial and/or needs assessment practices for caregivers, and c) the availability of and funding models for supportive care services for caregivers at community oncology practices (Objective 1), and 2) assess the perspectives of multi-disciplinary oncology health care providers regarding: a) perceived responsibility for, and barriers to, assessing and supporting caregivers, b) the importance of and self-efficacy in communicating with caregivers, and c) preferences regarding systems approaches to assess and meet caregivers' needs (Objective 2). Additionally, we will explore various practice and provider -level factors that are associated with the listed outcomes in objectives 1 and 2 respectively (Objective 3a and 3b). This study is estimated to enroll 138 Supportive Care Leaders (e.g., Director of Psychosocial Oncology, Supportive Care Services, or Cancer Patient Support) and 690 multidisciplinary Oncology Providers including physicians, nurses, and physician assistants/nurse practitioners. Participants will complete a one-time web-based survey (estimated at 15-20 minutes to complete). The supportive care leader survey will capture: (1) practice characteristics including caregiver identification and psychosocial assessment practices and preferences; supportive care resources; practice structure; practice technology resources; and status of the Caregiver Advise Record and Enable (CARE) Act. The oncology provider survey will capture: (1) provider skills in caregiver communication; perceived responsibility, knowledge and skills, and awareness of resources for meeting caregiver needs; barriers to meeting caregiver needs; provider characteristics; and system intervention preferences.

For data capture regarding supportive care leaders (Objective 1 and 3a), this will be a convenience sample of responders from all WF NCORP sites, therefore no randomization or stratification is necessary.

Regarding objectives pertaining to oncology providers (Objective 2 and 3b), participating sites with corresponding supportive care leaders will identify an appropriate supportive care leader to generate 3 lists of providers: 1) physicians, 2) nurses, and 3) physician assistants/nurse practitioners who routinely provide cancer care (Oncology Care Provider Identification Form, Appendix B). Using previous Landscape data regarding oncology physicians, we estimate that 50% of practice groups have 1-9 oncology physicians, 25% have 10-20, and 25% have 20+ physicians. After practices respond with lists of physicians, nurses, and physician assistants/nurse practitioners, we will classify each site as small, medium, and large using the criteria for physicians listed above. Assuming similar distributions as seen in Landscape, we will randomly sample 4, 12, and 20 total providers at small, medium, and large sites respectively. With approximately 50% of practices participating, we plan to target a weighted average of 10 providers per practice with the goal of a weighted average of 5 completed provider surveys (50% response/practice) for a total of 690 providers included in objective 2 (sample size justification follows in section 9.3). In addition, we will stratify and proportionally allocate by provider types identified at each site using self-weighting samples supplied in their lists of providers. Therefore of those randomly sampled, we will target roughly the same proportion of physicians, nurses, and PA/nurse practitioners as identified from their site administrator. Coordinators at each NCORP practice will provide e-mail addresses only for randomly selected providers (selected numbers from a numbered list), based on the size of the center and stratified proportional to provider types.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 828 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort
Supportive Care Leader
A staff member who is knowledgeable about supportive care services for adult oncology patients.
Oncology Providers
Physicians, nurses, physicians assistants, nurse practitioners who routinely provide cancer care to adult oncology patients.



Primary Outcome Measures :
  1. Percent of Practices that have Mechanisms in Place to Identify Primary Caregivers [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Practices that have a mechanism in place to identify and document a primary, informal caregiver for cancer patients will be identified by using the following Landscape 2017 Survey item: "Does your practice have a mechanism in place to identify and document a primary, informal (unpaid) caregiver for cancer patients?"

  2. Percent of Practices that have Mechanisms in Place to Provide Psychosocial and/or Needs Assessments for Caregivers [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Methods, documentation, settings and timing will be collected and assessed from practices that have mechanisms in place to identify primary caregivers.

  3. Percent of Practices that have Availability of and Funding Models for Supportive Care Services [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Percent of practices that have availability of and funding models for supportive care services provided to patients only, caregivers only, or both patients and caregivers will be assessed using items and content adapted from the Service Availability Measure and the Supportive Care Resources surveys.

  4. Providers' Perceived Responsibility per SPARCCS [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Questions used to collect perceived responsibility are adapted from the Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) on a scale of 0-4, "strongly disagree" to "strongly agree". These questions assess modifiable constructs that can be targeted for systems level interventions including: 1) questions assessing perceived responsibility for assessing caregivers; 2) questions assessing skills and time to support caregivers; and 3) questions assessing awareness of resources for caregivers in practice and community.

  5. Providers' Perceived Responsibility for Barriers to Meeting Caregiver Needs [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Barriers to meeting needs of caregivers will be assessed using a 20-item tool designed by our team in prior research which was adapted for this study. Providers will report the extent to which they believe each barrier (e.g., time, lack of specialized staff, reimbursement) impacts service delivery for caregivers on a scale of 0-3, "not a barrier at all" to "Major barrier".

  6. Providers' Ratings of Perceived Importance of Skills in Caregiver Communication [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Providers' perceived skills in caregiver communication assesses providers' perceived importance, self-efficacy, and need for more training in 4 caregiver communication skills: 1) educating caregivers about ways to support a care recipient during treatment and recovery, 2) detecting when caregivers are anxious, depressed, or overwhelmed, 3) providing information about resources available to support caregivers, 4) assessing problems between caregivers and patients that impact patient treatment or recovery (15 items). These 15 items are adapted from a provider patient communication instrument on a scale of 0-4, "not at all" to "extremely/very much".

  7. Providers' System Intervention Preferences [ Time Frame: Included in One-Time Web-Based Survey; Up to 20 minutes Total ]
    Providers' system intervention preferences will be assessed with 13 items assessing providers' preferences for offering different types of system interventions on a scale of 0-4, "not alt all interested" to "extremely interested"; 12 items assessing willingness and preferences for receiving training in each type of systems intervention on a scale of 0-2, "definitely" to "no".



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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This study will be open to all Adult NCORP Components and Sub-components. Participants will include supportive care leaders (staff member who is most knowledgeable about supportive care services) and multidisciplinary oncology providers (physicians, nurses, and physician assistants/nurse practitioners who routinely provide cancer care and have been in practice at component/subcomponent for at least 6 months).
Criteria

Inclusion Criteria:

  • NCI Community Oncology Research Program (NCORP) components/subcomponents providing care to adult oncology patients.
  • NCORP components/subcomponents willing to: a) identify a supportive care leader knowledgeable about supportive care services that may be available to the practice and b) assist with the identification and recruitment of oncology providers for a brief provider survey.
  • NCORP components/subcomponents who share staff and supportive care services may participate as a single practice group
  • A staff member at each site who is most knowledgeable about supportive care services for adult oncology patients (e.g., Director of Manger of Psychosocial Oncology, Supportive Care Services, or Cancer Patient Support). If an administrator or leader cannot be identified, the nurse manager or clinic director will be asked to identify a staff member most knowledgeable about psychosocial or supportive care services for adult oncology patients or complete the survey himself or herself.
  • Must be a physician, nurse, or physician assistant/nurse practitioner, who routinely provides cancer care to adult oncology patients, including medical, radiation and surgical oncologists or physician assistants (PAs), nurse practitioners (NPs), and nurses who work in oncology settings.
  • Must have been in practice at component/subcomponent for at least 6 months.

Exclusion Criteria:

  • Component/subcomponent exclusively care for pediatric oncology patients. Given the distinct caregiver experience and needs of caregivers of pediatric oncology patients, we are not including components/sub-components that exclusively provide care for pediatric oncology patients.
  • Providers in practice less than 6 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): NCT03746314


Contacts
Layout table for location contacts
Contact: Karen Craver, MT, MHA 3367134394 NCORP@wakehealth.edu
Contact: Jenna Gerosa 3367165992 NCORP@wakehealth.edu

Locations
Layout table for location information
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Medical University of South Carolina
Investigators
Layout table for investigator information
Principal Investigator: Chandylen Nightingale, PhD Wake Forest University Health Sciences
Principal Investigator: Katherine Sterba, PhD Medical University of South Carolina

Additional Information:
Publications:
Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) [Internet]. [cited 2018 Feb 19]. Available from: https://healthcaredelivery.cancer.gov/sparccs/
PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
95% Confidence Intervals for a Proportion [Internet]. Available from: http://web1.sph.emory.edu/cdckms/proportionDEFF.html
Levy PS, Lemeshow S. Sampling of populations: methods and applications. 4th ed. Hoboken, N.J: Wiley; 2008. 576 p. (Wiley series in survey methodology).
Lohr, Sharon. Sampling: Design and Analysis. Belmont, CA: Duxbury Press, 1999. Chapter 11.
Condition-Specific Research | National Alliance for Caregiving [Internet]. [cited 2017 Oct 13]. Available from: http://www.caregiving.org/research/condition-specific/

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03746314     History of Changes
Other Study ID Numbers: IRB00054509
WF-1803CD ( Other Identifier: NCI )
3UG1CA189824-04S1 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Time Frame: 6 months after publication for a 2 year duration.
Access Criteria: upon request to NCORP@wakehealth.edu

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Caregivers
Oncology
Cancer