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

NCT ID: NCT03045003

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A: Low Intensity

RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit.

Group Type: OTHER

RESIL Intervention

Intervention Type: 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.

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)

Group Type: OTHER

RESIL Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Accepts Healthy Volunteers: No

Sponsors

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role: collaborator

Hôpital Fribourgeois

OTHER

Sponsor Role: collaborator

University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role: collaborator

Manuela Eicher

OTHER

Sponsor Role: lead

Responsible Party

Manuela Eicher

Professeure Associée

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manuela Eicher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Other Identifiers

RESIL Trial

Identifier Type: -

Identifier Source: org_study_id