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

Manuela Eicher

Status: Completed

Conditions: Solid Tumor, Adult

Treatments: Behavioral: RESIL Intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03045003

RESIL Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Arm A: Low Intensity

Other group

Description:

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

Treatment:

Behavioral: RESIL Intervention

Arm B: High Intensity

Other group

Description:

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)

Treatment:

Behavioral: RESIL Intervention