Viewing Study NCT04626349



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Last Modification Date: 2024-10-26 @ 1:49 PM
Study NCT ID: NCT04626349
Status: COMPLETED
Last Update Posted: 2024-06-12
First Post: 2020-10-27

Brief Title: International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families
Sponsor: Vrije Universiteit Brussel
Organization: Vrije Universiteit Brussel

Study Overview

Official Title: International Randomized Controlled Trial to Evaluate the Effectiveness of a Nurse-delivered FOCUS and a Web-based iFOCUS Psychoeducational Intervention for People With Advanced Cancer and Their Family Caregivers
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIAdIC
Brief Summary: The overall aim of this project is to evaluate the effectiveness cost-effectiveness and mechanisms of action of two psychoeducational interventions a face-to-face nurse-led intervention called FOCUS and an eHealth intervention called iFOCUS aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver Both interventions are compared to care as usual

Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads Tailoring is based on information about the dyad obtained at enrollment eg age relationship etc and the responses in the intervention sessions

The overarching aim is addressed by five core intervention components

1 supporting family involvement and improving the dyads mutual communication
2 supporting outlook ie increasing the dyads capacity to identify positive or meaningful aspects related to their situation
3 increasing dyads coping skills ie their capacity to identify their coping strategies and take action
4 help dyads reduce their uncertainty
5 teaching symptom management and giving them confidence to handle specific tasks and problems

Project objectives

1 To compare 1 the face-to-face FOCUS intervention and 2 the iFOCUS web intervention to 3 care as usual in terms of their

Effect on the emotional function and self-efficacy primary outcomes appraisal of illness uncertainty hopelessness coping dyad communication quality of life and healthcare resource use of patients with advanced cancer and their family caregivers
Cost-effectiveness
Effects on vulnerable subgroups particularly women and those of lower socioeconomic status
Effectiveness in different healthcare systems
2 To evaluate the implementation process of the interventions in terms of the acceptability feasibility usefulness as perceived by patients family caregivers and healthcare staff in each country and their mechanisms of action

Data will be collected three times from patient-caregiver dyads 1 baseline measure t0 after which the dyad will immediately be randomized to one of the study arms 2 first follow-up at 12 weeks after baseline t1 and 3 second follow-up at 24 weeks after baseline t2
Detailed Description: STUDY SETTING

Both interventions FOCUS and iFOCUS will be administered in the homes of the patient-caregiver dyads or in the location of the dyads preference

The intervention will be conducted in six countries Belgium Denmark Ireland Italy the Netherlands and the United Kingdom In each country patients with advanced cancer and their primary family caregiver will be recruited and enrolled via participating hospitals Inclusion criteria for hospitals participating in this study are having 1 to treat patients with advanced cancer and 2 an oncology care regimen

SAMPLE SIZE

For the emotional functioning the EF10 subscale from the EORTC is used For self-efficacy the CASE instrument is used The investigators consider demonstration of an intervention effect for each of both interventions on at least one of these primary outcomes for either the patient or the caregiver at t1 as a success A pre-determined strict fixed sequence FS procedure defines prospectively hierarchical ordering of the endpoints for this study the hierarchical order is emotional functioning 1 and self-efficacy 2 Testing of null hypotheses proceeds according to their hierarchical order that is H10 is tested first at a significance level of 5 and if H10 is rejected then H20 is tested at the same significance level otherwise H20 is not tested at all The strict FS approach has the highest power for testing the first hypothesis outcome emotional function compared to the other methods as it does not save any portion of alpha for testing later hypothesis The reference mean value from EORTC for all cancer patients stage III-IV is 715 SD 238 Alpha is set at 00125 instead of 005 to account for multiplicity 2 comparisons with control group 2 participant groups patients and caregivers 1-beta ie statistical power is set at 09 The expected difference between the control group and the intervention arms in the primary outcomes is 0375 SD at t1 12 weeks

With these parameters n 203 is needed in each arm across all countries ie 609 in total Anticipating a 65 retention rate at t1 which is more conservative than found in previous studies in the USA on the FOCUS interventions due to the advanced cancer population included in this study 938 dyads must be enrolled across the 6 countries 313 per group This means n 156 need to be enrolled in total in each country n52 in each of the 3 arms per country Based on previous studies in the USA an enrolment rate of 55 is expected of those dyads referred to the study meaning that about 282 dyads will need to be screened and identified in each country The feasibility of recruitment has been evaluated based on previous research and discussions with clinicians in eligible hospitals

DATA ANALYSIS

Four main quantitative analyses will take place

1 Primary hypotheses testing

1 Testing the null hypothesis of the first primary endpoint emotional functioning The effectiveness of the FOCUS face-to-face intervention and the iFOCUS web-based intervention will be compared with the standard care control group for each participant population patientscaregivers separately In total 4 comparisons are performed for one outcome variable alpha00125 The hypotheses related to the first primary outcome emotional functioning will be tested using a mixed model per participant population with the T1 measurement value for emotional functioning as outcome variable recruitment center as random effect and randomization group and baseline measure of emotional functioning T0 as predictor variables Analyses will be performed on both intention-to-treat and per-protocol principles The primary principle is intention-to-treat After completion of the baseline measurement T0 dyads will be randomized to one of the trial arms All randomized dyads will be included in the mixed model Multiple imputation will be applied Predictors for the imputation model will include the baseline measurement randomization group age and other variables eg severity of the illness The secondary principle is the per-protocol analysis that functions as a sensitivity analysis The per-protocol population will be defined as dyads who have completed all sessions of the FOCUS or iFOCUS intervention except for dyads in the control group and T1 measurement By including the baseline measurement as a predictor variable ANCOVA preexisting differences will be controlled enhancing the sensitivity of the analyses To interpret the magnitude of the effects for the different outcomes effect sizes Cohens d will be estimated
2 Testing the null hypothesis of the second primary endpoint self-efficacy the Lewis Cancer self-efficacy scale from FOCUS As per the fixed sequence FS procedure the null hypotheses of the second primary endpoint self-efficacy will only be tested if a significant result is found for the first primary endpoint emotional function The same strategy is then followed for the analyses as for the first primary endpoint with an alpha level of 00125
2 Secondary hypotheses testing

All identified secondary endpoints Quality of Life including separate items of hopelessness anxiety depression benefits of illness coping dyad communication all at t1 will be evaluated by testing the FOCUS and iFOCUS will against care as usual control group for each participant population patientscaregivers separately In total 4 comparisons are performed for each outcome variable For each secondary outcome variable a mixed model is applied per participant population with the T1 measurement value as outcome variable recruitment center as random effect and randomization group and baseline measurement of the variable T0 as predictor variables Analyses will be performed on both intention-to-treat and per-protocol principles applying the same principles as described above

By including the baseline measurement as a predictor variable ANCOVA preexisting differences will be controlled enhancing the sensitivity of the analyses To interpret the magnitude of the effects for the different outcomes effect sizes Cohens d will be estimated All statistical tests will be two-sided and considered significant if p 00125

All primary outcomes and secondary outcomes as listed above will also be analysed at T2 6 months to evaluate longer term effects using the same analysis procedures

The cost-effectiveness of the interventions will be determined by analyzing patterns and costs of healthcare utilization and effects on quality of life measured by the EORTC EQ5D5L FACT G and CQOLC Data will also be collected on the types and amounts of informal care provided to patients in each arm of the study to investigate if amount or patterns of informal care change as a result of the intervention The outputs will be mean costs of care for patients in each arm of the study cost per year of life gained if survival is affected significantly by the intervention and the costs in the intervention groups overall are higher and if appropriate the additional costs of achieving better quality of life outcomes including estimates of cost per quality adjusted life year gained
3 Exploratory hypotheses testing

For all exploratory endpoints two-sided statistical tests will be considered significant if p 005
1 For the outcomes that are measured identical for the patient and the caregiver the effect on the dyad as a whole ie both patient and family caregiver will be assessed For the outcome instruments that led to comparable estimated differences between FOCUS and standard care and iFOCUS and standard care the effect will be assessed on the dyad as a whole by adding an extra level dyad to the linear regression model
2 For each of the primary and secondary endpoints subgroup analyses will be performed using formal interaction tests to explore the extent to which the outcomes of the trial differ by country gender and socioeconomic status Interaction terms between respectively country gender and socioeconomic status on the one hand and the trial arms on the other hand will be added to the analysis models For the country variation a multilevel mixed model analyses will also be performed to additionally account for potential clustering by country ie participants nested within a country Outcomes will be analyzed with country as random factor
4 Other analyses

1 Background reports describing care as usual for people with advanced cancer will facilitate the understanding of the results of the between-country comparisons
2 Process evaluation of the implementation of the interventions will be analyzed following the MRC framework for evaluating complex interventions integrating normalization process theory NPT and the RE-AIM framework Data analysis for the process evaluation will include a standard statistical descriptions of the quantitative data from the intervention checklist and routine monitoring to describe adherence to the implementation This analysis will determine cut-off points for good intervention adherence and hence inform the per-protocol analyses b analyses of the qualitative data semi-structured interviews with patients and their family caregiver and post-intervention interviews with the nurses who delivered the face-to-face FOCUS intervention will be performed see below - Qualitative analysis

Qualitative analysis

With the transcription of interviews into the local language the analysis process will involve a collaborative process involving researchers from each partner site collecting data Thematic analysis allows for both inductive and deductive analysis and can be implemented with a range of computer-based software to support the management of the analysis process eg NVIVO MAXQDA

Deductive analysis will be informed by semantic information sought from the interview ie were participants satisfied where particular elements of the programmes described as positive or negative and themes evident in previous evaluations of the FOCUS intervention This will involve developing themes in advance of the analysis process and assessing the presence or absence of these themes across the data Inductive analysis will be structured using the objectives of the process evaluation to target key topics with more latent or interpretative themes isolating more experiential findings from the data Qualitative analysis will be conducted at two levels an initial assessment of themes in each data source stakeholders staff researchers patients and carers different language groups followed by a higher-level analysis of superordinate themes of convergence and divergence evident across groups Additional strategies for managing the potential impact of multilingual analysis are recommended including peer debriefing during the process of coding and the development of candidate themes triangulation across researchers and language sources Analysis will be informed by open discussion of conceptual issues in the data to explore variations in interpretation and identify shared meaning relevant to the focus of the process evaluation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None