PARTICIPATING PATIENTS REACTIONS TO EARLY CLOSURE OF A CLINICAL TRIAL FOR NEGATIVE RESULTS

2.50
Hdl Handle:
http://hdl.handle.net/10755/165373
Category:
Abstract
Type:
Presentation
Title:
PARTICIPATING PATIENTS REACTIONS TO EARLY CLOSURE OF A CLINICAL TRIAL FOR NEGATIVE RESULTS
Author(s):
Bryce, Jane; Connola, Marianna; Salzano de Luna, Antonella; Caraco, Corrado; Grazia Chiofalo, Maria; Mozzillo, Nicola; Bell, Carol
Author Details:
Jane Bryce, RN, MSN, Research Nurse Coordinator, Istituto Nazionale dei Tumori, Fondazione G. Pascale, Napoli, Italy, email: janebryce@hotmail.com; Marianna Connola, Antonella Salzano de Luna, Corrado Caraco, Maria Grazia Chiofalo, Nicola Mozzillo, and Carol Bell
Abstract:
Topic: Clinical trial (CT) literature provides information on early stopping rules and the mechanics of closure of CTs, but little guidance is available to clinicians regarding support of the patient who must abruptly stop trial therapy. An initial step is to understand patients' reactions to early stopping. Purpose: The purpose of this study is to explore patients' reactions to the early closure of a negative CT while providing education and support to patients transitioning to a new phase of care. Framework: A cooperative inquiry framework was chosen to gain understanding together with patients and allow the clinical trial nurse (CTN) to provide nursing care through educational and supportive interventions. Methods: The study was conducted with 16 patients enrolled in an international phase III adjuvant therapy trial for stage IV melanoma (CancerVax MMAIT-4-001) when the study was closed early after interim analysis demonstrated unlikelihood of positive results. Patients were notified in person of study closure by Investigator and CTN. The CTN conducted follow up semi-structured interviews with patients 6-10 weeks after closure to determine: patient reaction to trial closure, further treatment sought, positive and negative experiences of participating in the CT, patient informational and emotional needs. A second session was conducted 14-16 weeks after closure to disclose treatment assignments. Interviews were caring interventions providing information, emotional support and insight to help patients' transition to the next phase of treatment. Findings were evaluated for themes by CTNs. All patients continue nursing follow up at regular intervals. Findings: Emerging themes related to closure were: initial fears of abandonment by the health care team and of doing nothing against the disease, both with diminishing impact at second interview. Positive experiences reported were perception of being cared for by the CTN, facilitated access to the health care team, and the treatment cohort as an informal support group. Negative experiences reported were being caught off-guard at study closure and the lack of treatment alternatives. Identified patient needs included reassurance, information on alternate therapies and impact of trial therapy on future options. The ongoing CTN-patient relationship provides a basis for meeting the multiple needs of patients when CTs are stopped early.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2006
Conference Name:
31st Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Boston, Massachusetts, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titlePARTICIPATING PATIENTS REACTIONS TO EARLY CLOSURE OF A CLINICAL TRIAL FOR NEGATIVE RESULTSen_GB
dc.contributor.authorBryce, Janeen_US
dc.contributor.authorConnola, Mariannaen_US
dc.contributor.authorSalzano de Luna, Antonellaen_US
dc.contributor.authorCaraco, Corradoen_US
dc.contributor.authorGrazia Chiofalo, Mariaen_US
dc.contributor.authorMozzillo, Nicolaen_US
dc.contributor.authorBell, Carolen_US
dc.author.detailsJane Bryce, RN, MSN, Research Nurse Coordinator, Istituto Nazionale dei Tumori, Fondazione G. Pascale, Napoli, Italy, email: janebryce@hotmail.com; Marianna Connola, Antonella Salzano de Luna, Corrado Caraco, Maria Grazia Chiofalo, Nicola Mozzillo, and Carol Bellen_US
dc.identifier.urihttp://hdl.handle.net/10755/165373-
dc.description.abstractTopic: Clinical trial (CT) literature provides information on early stopping rules and the mechanics of closure of CTs, but little guidance is available to clinicians regarding support of the patient who must abruptly stop trial therapy. An initial step is to understand patients' reactions to early stopping. Purpose: The purpose of this study is to explore patients' reactions to the early closure of a negative CT while providing education and support to patients transitioning to a new phase of care. Framework: A cooperative inquiry framework was chosen to gain understanding together with patients and allow the clinical trial nurse (CTN) to provide nursing care through educational and supportive interventions. Methods: The study was conducted with 16 patients enrolled in an international phase III adjuvant therapy trial for stage IV melanoma (CancerVax MMAIT-4-001) when the study was closed early after interim analysis demonstrated unlikelihood of positive results. Patients were notified in person of study closure by Investigator and CTN. The CTN conducted follow up semi-structured interviews with patients 6-10 weeks after closure to determine: patient reaction to trial closure, further treatment sought, positive and negative experiences of participating in the CT, patient informational and emotional needs. A second session was conducted 14-16 weeks after closure to disclose treatment assignments. Interviews were caring interventions providing information, emotional support and insight to help patients' transition to the next phase of treatment. Findings were evaluated for themes by CTNs. All patients continue nursing follow up at regular intervals. Findings: Emerging themes related to closure were: initial fears of abandonment by the health care team and of doing nothing against the disease, both with diminishing impact at second interview. Positive experiences reported were perception of being cared for by the CTN, facilitated access to the health care team, and the treatment cohort as an informal support group. Negative experiences reported were being caught off-guard at study closure and the lack of treatment alternatives. Identified patient needs included reassurance, information on alternate therapies and impact of trial therapy on future options. The ongoing CTN-patient relationship provides a basis for meeting the multiple needs of patients when CTs are stopped early.en_GB
dc.date.available2011-10-27T12:17:23Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:17:23Z-
dc.conference.date2006en_US
dc.conference.name31st Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationBoston, Massachusetts, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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