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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Behavioral: RESIL Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supportive Care Needs Survey 9 item version score changes	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	week 1 (first intervention application) and week 16

Collaborators and Investigators

• Sponsor: Manuela Eicher
• Collaborators: ETOP IBCSG Partners Foundation; Hôpital Fribourgeois; University of Applied Sciences of Western Switzerland
• Investigators: Principal Investigator: Manuela Eicher, PhD, University of Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Resilience, Supportive Care, Psychosocial Care, Nursing
• Other Study ID Numbers: RESIL Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No