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

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.

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Key information

Conditions

Solid Tumor, Adult

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RESIL Intervention

Behavioral

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 outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Manuela Eicher

Other

Collaborators

ETOP IBCSG Partners Foundation
Hôpital Fribourgeois
University of Applied Sciences of Western Switzerland

Registry information

Official study 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

Acronym: RESIL

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 7, 2017
Registry last updated: Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed