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

NCT03045003 | Completed

• 1 other identifier: RESIL Trial
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor, Adult

Keywords

Resilience, Supportive Care, Psychosocial Care, Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Supportive Care Needs Survey 9 item version score changes

  week 1 (first intervention application) and week 16

Study Arms (2)

Arm A: Low Intensity

OTHER

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

Behavioral: RESIL Intervention

Arm B: High Intensity

OTHER

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)

Behavioral: RESIL Intervention

Interventions

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.

Arm A: Low Intensity; Arm B: High Intensity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manuela Eicher: lead
• ETOP IBCSG Partners Foundation: collaborator
• Hôpital Fribourgeois: collaborator
• University of Applied Sciences of Western Switzerland: collaborator

Study Officials

• Manuela Eicher, PhD

  University of Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professeure Associée

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 7, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share