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

Solid Tumor, Adult Clinical Trial

— RESIL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045003
• Other study ID #: RESIL Trial
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: February 7, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2017
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Manuela Eicher	Hopital Fribourgeois, International Breast Cancer Study Group, University of Applied Sciences of Western Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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