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Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients (RESIL)

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: NCT03045003
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
International Breast Cancer Study Group
Hopital Fribourgeois
University of Applied Sciences of Western Switzerland
Information provided by (Responsible Party):
Manuela Eicher, University of Lausanne

Brief Summary:
The aim of this phase II study is to test by feasibility and efficacy of two interprofessional supportive care interventions with different intensities to facilitate resilience in patients and thereby to reduce their unmet supportive care needs.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Behavioral: RESIL Intervention Not Applicable

Detailed Description:

Intervention A (tested in arm A) includes screening of resilience and supportive care needs as well as direct feed-back of the screening results on a monitoring sheet to nurses and oncologists in charge of the patient. Nurses and oncologists follow three training sessions to be trained in a) resilience facilitation, b) interventions to adress supportive care needs, c) use of the monitoring sheet.

Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing the Feasibility and Efficacy of Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients: A Phase II TriaL
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Arm Intervention/treatment
Arm A: Low Intensity
RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit.
Behavioral: RESIL Intervention
Interventions tested in this study are the following: i) educational sessions with oncologists and nurses, ii) direct, electronic feed-back of resilience and needs screening in a monitoring sheet including intervention propositions and iii) consultation provided by a clinical nurse specialist to patients (in intervention B only) Interventions have been developed based on previous studies on the efficacy of screening of patient reported outcomes and direct feed-back to health care professionals and on previous studies on interventions to enhance resilience in nursing or psycho-oncology with proven efficacy. Interventions provided in the monitoring sheet have been validated by experienced Swiss oncology nurses, oncologists and psycho-oncologists.

Arm B: High Intensity
RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit plus 5 nurse-led consultations (3 face-to-face and 2 telephone consultations)
Behavioral: RESIL Intervention
Interventions tested in this study are the following: i) educational sessions with oncologists and nurses, ii) direct, electronic feed-back of resilience and needs screening in a monitoring sheet including intervention propositions and iii) consultation provided by a clinical nurse specialist to patients (in intervention B only) Interventions have been developed based on previous studies on the efficacy of screening of patient reported outcomes and direct feed-back to health care professionals and on previous studies on interventions to enhance resilience in nursing or psycho-oncology with proven efficacy. Interventions provided in the monitoring sheet have been validated by experienced Swiss oncology nurses, oncologists and psycho-oncologists.




Primary Outcome Measures :
  1. Connor Davidson Resilience Scale Score Change [ Time Frame: week 1 (first intervention application) and week 16 ]
    Number of patients expressing a CD-RISK score change of ≥ 5 in arms A and B


Secondary Outcome Measures :
  1. Supportive Care Needs Survey 9 item version score changes [ Time Frame: week 1 (first intervention application) and week 16 ]
    Number of patients expressing a score change in the physical and patient care needs domain and a score change of ≥ 5 in the psychological and informational needs domain of the SCNS 9 in arms A and B



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years and older
  • attending the clinic for the first chemotherapy administration
  • newly diagnosed (between 4-15 weeks after diagnosis) with a new carcinoma / lymphoma
  • sufficiently literate in French or German to complete questionnaires.

Exclusion Criteria:

  • recurrent disease
  • being treated in in-patient or palliative care units
  • diagnosed with all other cancers
  • in need of complex chemotherapy
  • being judged by the oncologist as not being emotionally or physically capable to participate in the trial will be excluded.

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): NCT03045003


Sponsors and Collaborators
Manuela Eicher
International Breast Cancer Study Group
Hopital Fribourgeois
University of Applied Sciences of Western Switzerland
Investigators
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Principal Investigator: Manuela Eicher, PhD University of Lausanne

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Responsible Party: Manuela Eicher, Professeure Associée, University of Lausanne
ClinicalTrials.gov Identifier: NCT03045003    
Other Study ID Numbers: RESIL Trial
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Manuela Eicher, University of Lausanne:
Resilience, Supportive Care, Psychosocial Care, Nursing