Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients
- Conditions
- Solid Tumor, Adult
- Interventions
- Behavioral: RESIL Intervention
- Registration Number
- NCT03045003
- Lead Sponsor
- Manuela Eicher
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 86
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: High Intensity RESIL Intervention 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) Arm A: Low Intensity RESIL Intervention RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit.
- Primary Outcome Measures
Name Time Method Connor Davidson Resilience Scale Score Change 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 Outcome Measures
Name Time Method Supportive Care Needs Survey 9 item version score changes 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