Solid Tumor, AdultRESILNCT03045003
Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients
A study testing RESIL Intervention in people with Solid Tumor, Adult, run by Manuela Eicher.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- RESIL Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read the 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
- Being tested
- RESIL Intervention
- Keywords
- Resilience, Supportive Care, Psychosocial Care, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESIL InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Low Intensity | Other | RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit. Receives: 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) Receives: Behavioral: RESIL Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connor Davidson Resilience Scale Score Change
Number of patients expressing a CD-RISK score change of ≥ 5 in arms A and B
Measured: week 1 (first intervention application) and week 16
Secondary outcomes (1)
Supportive Care Needs Survey 9 item version score changes
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
Measured: week 1 (first intervention application) and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuela Eicher
- Sponsor type
- University, hospital or other
- Collaborators
- ETOP IBCSG Partners Foundation, Hôpital Fribourgeois, University of Applied Sciences of Western Switzerland
- Responsible party
- Sponsor-investigator, Manuela Eicher, University of Lausanne
- Investigators
- Manuela Eicher, PhD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045003
- Sponsor's protocol ID
- RESIL Trial
- Acronym
- RESIL
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03045003
- Acronym / sponsor ID
- RESIL / RESIL Trial
- Conditions
- Solid Tumor, Adult
- Keywords
- Resilience, Supportive Care, Psychosocial Care, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Manuela EicherUniversity, hospital or other
- Collaborators
- ETOP IBCSG Partners Foundation, Hôpital Fribourgeois, University of Applied Sciences of Western Switzerland
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Low Intensity | Other | Behavioral: RESIL InterventionRESIL Intervention provided by nurses and oncologists of the outpatient oncology unit. |
| Arm B: High Intensity | Other | Behavioral: RESIL InterventionRESIL Intervention provided by nurses and oncologists of the outpatient oncology unit plus 5 nurse-led consultations (3 face-to-face and 2 telephone consultations) |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESIL InterventionInterventions 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. | Behavioural | Arm A: Low Intensity, Arm B: High Intensity |
Primary outcome
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
1 secondary outcome
Supportive Care Needs Survey 9 item version score changes
Time frame: week 1 (first intervention application) and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Eicher, PhD principal investigator
University of Lausanne
Questions about this trial
What is this clinical trial studying?
A study testing RESIL Intervention in people with Solid Tumor, Adult, run by Manuela Eicher.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connor Davidson Resilience Scale Score Change (time frame: week 1 (first intervention application) and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.