Clinical trial NCT04173897: Living Better With Advanced Breast Cancer: Feasibility Evaluation of an Online Supportive Intervention.
Official title: Living Better With Advanced Breast Cancer (LIBERATE) Phase II: Evaluating the Feasibility of a Supportive, Self-management Website in Women Living With Secondary Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Breast Cancer Now
First posted: 2019-11-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, two-arm randomised model using a waiting list control design.

\[A separate single arm study (non-randomised, pre-post design) will run in parallel, recruiting via online channels.\]
Primary purpose: OTHER

Brief summary: The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support.

This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.

Detailed description: Despite ongoing treatment advances for women living with secondary (metastatic, stage IV, advanced) breast cancer, quality of life (QoL) remains a crucial concern. Patients' diverse psycho-social and supportive needs are widely reported to be poorly understood and inadequately addressed.

The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer.

Phase I of the LIBERATE project informed intervention development though several strands:

1. Semi-structured interviews with patients and health \& charity professionals explored the supportive needs and factors affecting the quality of life of women living with secondary breast cancer. This guided the components and content of the online intervention.
2. A systematic review of online interventions in the context of advanced cancer was also conducted. This guided the design and delivery of the online intervention.

The final intervention comprises five components delivered via an interactive website;

* A wide range of holistic health information specific to secondary breast cancer.
* Online symptom monitoring questionnaire generating tailored self-management advice with results available for clinician review.
* Case studies of a diverse range of women living with secondary breast cancer.
* Signposting to services and resources specific to secondary breast cancer.
* Support for others affected by a diagnosis of secondary breast cancer. The overall aims of the LIBERATE intervention are to better address the supportive needs and to improve the quality of life of women living with secondary breast cancer.

Aims and objectives: In this feasibility randomised controlled trial, the investigators plan to test the complete LIBERATE intervention, including the clinical integration of users' symptom monitoring questionnaire results with their electronic medical records.

The investigators aim to examine the feasibility, acceptability and adherence to the online intervention from the perspective of women living with secondary breast cancer and to explore the effect of the intervention on their quality of life and self-efficacy in managing their cancer. The investigators aim to determine effect sizes to inform a potential future larger scale randomised controlled trial.

Eligibility and study design:

Adult females with a diagnosis of secondary breast cancer and access to the internet who are receiving their care at St James' University Hospital, Leeds, will be eligible to take part in this study.

This study will be a prospective randomised controlled feasibility trial using a waiting list control design, repeated measures and mixed methods. Participants will be randomised (following a 1:1 randomisation strategy) to either receive the intervention or to be assigned to a waiting list to receive access to the intervention following study completion. Those on the waiting list will receive care and support as usual during the study period. The investigators aim to recruit a maximum of 30 patients to the study.

Participants in the intervention arm will receive training to navigate the LIBERATE website and complete the online symptom monitoring questionnaires from home. They will be free to use the website as much or as little as they choose over the 12 week study period. They will be reminded to complete a symptom monitoring questionnaire at least once per week. Their health professionals will be able to view the results of their symptom monitoring questionnaires and act on the information accordingly. Alerts will also be sent out to the relevant clinician when patients report any severe symptoms.

All participants (within both the intervention and the waiting list control arm) will complete paper-based self-report questionnaires measuring quality of life and self-efficacy at baseline and at 12 weeks.

A separate single-arm sub study will also recruit approximately 15 women with secondary breast cancer (bringing the overall recruitment target to 45) who are being cared for outside of the Leeds Teaching Hospitals Trust. The aim of this study is to explore whether participants outside of Leeds find symptom monitoring and the overall website useful without the function for linking to their medical records. Participants will fill in questionnaires asking about their QoL and confidence in self-managing their cancer before and after the study.

Study measures:

This study will use a range outcome measures to compare the LIBERATE intervention with care as usual (waiting list control):

Patient reported outcome measures: Validated questionnaires will be used to measure quality of life (EQ-5D-5L and FACT-B) and self-efficacy (CBI-B and SEMCD-6).

Clinical process measures: including number of clinician alerts generated, number of Clinical Nurse Specialist contacts in intervention period, calls to hospital and number of visits to hospital during intervention period.

End of study interviews: semi-structured interviews with participants and health professionals will explore acceptance and experiences of using the LIBERATE intervention.

Overall findings will determine the feasibility and value of a self-management, symptom-monitoring and signposting website as a supportive intervention for women living with and being treated for secondary breast cancer.

Eligibility criteria: Inclusion Criteria:

* Adult females (aged 18 and over).
* Diagnosed with secondary (metastatic, stage IV) breast cancer.
* Access to the internet.

Exclusion Criteria:

* Exhibiting signs of overt psychopathology or cognitive dysfunction.
* Current involvement in other clinical trials involving completion of QoL or other patient reported outcome measures.

Primary outcomes:
measure: Number of participants with self-reported outcome data at 12 weeks.
timeFrame: 12 weeks.
measure: Proportion of missing data in self-report outcome questionnaires.
timeFrame: 12 weeks.
measure: Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (EQ-5D-5L).
timeFrame: 12 weeks
measure: Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (FACT-B).
timeFrame: 12 weeks
measure: Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (B-CBI).
timeFrame: 12 weeks
measure: Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (SEMCD-6).
timeFrame: 12 weeks
measure: Acceptability & use of intervention: Number of symptom monitoring reports generated and qualitative interview data.
timeFrame: 12 weeks
Secondary outcomes:
measure: Estimation of effect size for QOL using participant scores for EQ-5D-5L.
timeFrame: 12 weeks
measure: Estimation of effect size for QOL using participant scores for FACT-B.
timeFrame: 12 weeks
measure: Estimation of effect size for self-efficacy using participant scores for B-CBI.
timeFrame: 12 weeks
measure: Estimation of effect size for self-efficacy using participant scores for SEMCD-6.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: West Yorkshire
Study officials:
References: