Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06082128
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-09-20
Brief Title:
FOCUSau A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
Improving the Wellbeing of People With Advanced Cancer and Their Family Carers An Effectiveness Implementation Trial of an Australian Dyadic Digital Health Intervention FOCUSau
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
FOCUSau
Brief Summary:
FOCUS is a dyadic psychoeducational intervention developed in the USA shown to improve the wellbeing and quality of life QoL of patients with advanced cancer and their primary family carers The intervention consists of five core components underpinning the FOCUS acronym
F supporting Family involvement O supporting Outlook and meaning C increasing Coping effectiveness U reducing Uncertainty and S Symptom management Originally a nurse-delivered in-person intervention FOCUS has been translated into a self-administered web-based intervention as part of an European study
The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention FOCUSau aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support personcarer
A primary support personcarer is an unpaid individual identified by the person with advanced cancer not necessarily a partner or family member who is providing them with physical social or emotional support Hereafter referred to as a carer The term dyad refers to the patient and primary support personcarer
The project objectives are
1 adapt FOCUS to the Australian context and develop FOCUSau
2 examine the effectiveness of FOCUSau in improving the wellbeing primary outcomes QoL and self-efficacy of patients with advanced cancer and their primary family carer
3 compare the type and costs of health service use by participants in the intervention and control group and
4 assess the acceptability feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system
A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support personcarer
Data will be collected three times from patient-carer dyads
1 at baseline T0 after which the dyad will immediately be randomised 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
F supporting Family involvement O supporting Outlook and meaning C increasing Coping effectiveness U reducing Uncertainty and S Symptom management Originally a nurse-delivered in-person intervention FOCUS has been translated into a self-administered web-based intervention as part of an European study
The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention FOCUSau aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support personcarer
A primary support personcarer is an unpaid individual identified by the person with advanced cancer not necessarily a partner or family member who is providing them with physical social or emotional support Hereafter referred to as a carer The term dyad refers to the patient and primary support personcarer
The project objectives are
1 adapt FOCUS to the Australian context and develop FOCUSau
2 examine the effectiveness of FOCUSau in improving the wellbeing primary outcomes QoL and self-efficacy of patients with advanced cancer and their primary family carer
3 compare the type and costs of health service use by participants in the intervention and control group and
4 assess the acceptability feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system
A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support personcarer
Data will be collected three times from patient-carer dyads
1 at baseline T0 after which the dyad will immediately be randomised 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
The patient-carer dyads will be recruited via two methods 1 referral from hospitals or 2 self-referral For method one approximately six hospitals andor cancer centres metropolitan and regional across Australia will be selected For the self-referral recruitment method patients who have been made aware of the project but have not been officially screened by a clinician may self-refer via a webform on the project website These patients will be made aware via consumercarercancer advocacy groups or social media advertisement
SAMPLE SIZE
A pre-determined strict fixed sequence FS procedure defines prospectively hierarchical ordering of the primary endpoints emotional wellbeing 1 and self-efficacy 2 Testing of null hypotheses proceeds according to their hierarchical order that is hypothesis 1 H10 is tested first at a significance level of 5 and if H10 is rejected then hypothesis 2 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 wellbeing compared to the other methods as it does not save any portion of alpha for testing later hypothesis The reference mean value from The European Organization for Research and Treatment of Cancer EORTC for all cancer patients stage III-IV is 715 SD 238 To maintain rigorous control over Type I errors due to multiple comparisons the alpha level is set at 0025 instead of the more common 005 This adjustment accounts for the multiple comparisons required in the study including comparisons between a control group and two participant groups patients and carers Statistical power is set at 080 The expected difference between the control group and the intervention arm in the primary outcomes is 0375 SD at T1 12 weeks With these parameters n173 dyads are needed in each arm ie 346 dyads in total Anticipating a maximum 80 retention rate at T1 USA FOCUS retention was 86 approximately 433 dyads will need to be recruited An enrolment rate of 55 of those eligible was achieved in prior digital health FOCUS study from 2014 however it is anticipated this will be higher for FOCUSau estimating 70 given the internet is much more widely available now and the digital recruitment approach meaning that approximately 618 dyads who meet eligibility criteria will need to be identified Evidence also suggests that recruitment rates can increase when a digital health intervention is offered
DATA ANALYSIS
The effectiveness of FOCUSau will be compared with the standard care control group for each participant population patientscarers using significance level of alpha0025 The hypotheses will be tested using a mixed model per participant population with the T1 measurement values for emotional wellbeing and self-efficacy as primary outcomes These mixed models will be implemented using International Business Machines Corporation IBM Statistical Package for the Social Sciences SPSS for Windows Version 270 and R with recruitment centre treated as a random effect and randomisation group as predictor variables 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 wellbeing Additionally other factors identified in the literature will be incorporated as potentially predictive by including them as covariates in the mixed models Analyses on both intention-to-treat and per-protocol principles will be performed To interpret the magnitude of the effects for the different outcomes effect sizes will be estimated Cohens d
The data analysis will encompass all primary and secondary outcomes Primary endpoints including emotional wellbeing and self-efficacy measured at T1 will be analysed first Following that secondary endpoints comprising outcomes measured at T1 that are not primary endpoints as well as all outcomes measured at T2 occurring 24 weeks from T0 will be assessed This approach allows for a comprehensive evaluation including the examination of longer-term effects
The robustness and validity of the results will be explored using sensitivity analyses by varying the parameter inputs including sensitivity to the use of values for missing observations The analysis will be conducted for the within trial period the potential to extrapolate results over the longer-term will be assessed based on the proportion of patients alive at the end of follow-up
The cost-effectiveness analysis will be reported as the mean costs of care per dyad in each arm of the study Costs applied to health care service use will be as per Australian standard fees eg via the Medicare Benefits Schedule If a difference in outcomes is observed as hypothesised the incremental cost effectiveness of FOCUSau compared with control will be estimated in terms of the 1 cost per additional patient with a meaningful improvement in emotional wellbeing as assessed using the EORTC QLQ-C30 emotional wellbeing scale and separately 2 cost per additional carer with a meaningful change in self-efficacy as assessed using the The Lewis Cancer self-efficacy scale The base case analysis of cost-effectiveness will be conducted from a health care system perspective Subsequent sensitivity analyses will modify the assessment of costs to adopt a societal perspective to capture the impact of informal care costs as well as testing the robustness of the analysis results to variations in other parameter inputs
Missing data for costs and outcomes will be described and summarised Where missing data can be regarded as missing at random likelihood interpolation methods will be used for analysis of those data as appropriate
The patient-carer dyads will be recruited via two methods 1 referral from hospitals or 2 self-referral For method one approximately six hospitals andor cancer centres metropolitan and regional across Australia will be selected For the self-referral recruitment method patients who have been made aware of the project but have not been officially screened by a clinician may self-refer via a webform on the project website These patients will be made aware via consumercarercancer advocacy groups or social media advertisement
SAMPLE SIZE
A pre-determined strict fixed sequence FS procedure defines prospectively hierarchical ordering of the primary endpoints emotional wellbeing 1 and self-efficacy 2 Testing of null hypotheses proceeds according to their hierarchical order that is hypothesis 1 H10 is tested first at a significance level of 5 and if H10 is rejected then hypothesis 2 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 wellbeing compared to the other methods as it does not save any portion of alpha for testing later hypothesis The reference mean value from The European Organization for Research and Treatment of Cancer EORTC for all cancer patients stage III-IV is 715 SD 238 To maintain rigorous control over Type I errors due to multiple comparisons the alpha level is set at 0025 instead of the more common 005 This adjustment accounts for the multiple comparisons required in the study including comparisons between a control group and two participant groups patients and carers Statistical power is set at 080 The expected difference between the control group and the intervention arm in the primary outcomes is 0375 SD at T1 12 weeks With these parameters n173 dyads are needed in each arm ie 346 dyads in total Anticipating a maximum 80 retention rate at T1 USA FOCUS retention was 86 approximately 433 dyads will need to be recruited An enrolment rate of 55 of those eligible was achieved in prior digital health FOCUS study from 2014 however it is anticipated this will be higher for FOCUSau estimating 70 given the internet is much more widely available now and the digital recruitment approach meaning that approximately 618 dyads who meet eligibility criteria will need to be identified Evidence also suggests that recruitment rates can increase when a digital health intervention is offered
DATA ANALYSIS
The effectiveness of FOCUSau will be compared with the standard care control group for each participant population patientscarers using significance level of alpha0025 The hypotheses will be tested using a mixed model per participant population with the T1 measurement values for emotional wellbeing and self-efficacy as primary outcomes These mixed models will be implemented using International Business Machines Corporation IBM Statistical Package for the Social Sciences SPSS for Windows Version 270 and R with recruitment centre treated as a random effect and randomisation group as predictor variables 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 wellbeing Additionally other factors identified in the literature will be incorporated as potentially predictive by including them as covariates in the mixed models Analyses on both intention-to-treat and per-protocol principles will be performed To interpret the magnitude of the effects for the different outcomes effect sizes will be estimated Cohens d
The data analysis will encompass all primary and secondary outcomes Primary endpoints including emotional wellbeing and self-efficacy measured at T1 will be analysed first Following that secondary endpoints comprising outcomes measured at T1 that are not primary endpoints as well as all outcomes measured at T2 occurring 24 weeks from T0 will be assessed This approach allows for a comprehensive evaluation including the examination of longer-term effects
The robustness and validity of the results will be explored using sensitivity analyses by varying the parameter inputs including sensitivity to the use of values for missing observations The analysis will be conducted for the within trial period the potential to extrapolate results over the longer-term will be assessed based on the proportion of patients alive at the end of follow-up
The cost-effectiveness analysis will be reported as the mean costs of care per dyad in each arm of the study Costs applied to health care service use will be as per Australian standard fees eg via the Medicare Benefits Schedule If a difference in outcomes is observed as hypothesised the incremental cost effectiveness of FOCUSau compared with control will be estimated in terms of the 1 cost per additional patient with a meaningful improvement in emotional wellbeing as assessed using the EORTC QLQ-C30 emotional wellbeing scale and separately 2 cost per additional carer with a meaningful change in self-efficacy as assessed using the The Lewis Cancer self-efficacy scale The base case analysis of cost-effectiveness will be conducted from a health care system perspective Subsequent sensitivity analyses will modify the assessment of costs to adopt a societal perspective to capture the impact of informal care costs as well as testing the robustness of the analysis results to variations in other parameter inputs
Missing data for costs and outcomes will be described and summarised Where missing data can be regarded as missing at random likelihood interpolation methods will be used for analysis of those data as appropriate
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APP2006170 | OTHER_GRANT | National Health and Medical Research Council NHMRC | None |