Living Better With Advanced Breast Cancer: Feasibility Evaluation of an Online Supportive Intervention.

NCT04173897 | Completed

• 1 other identifier: NOV2016PhD818
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (7)

• Number of participants with self-reported outcome data at 12 weeks.

  Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).

  12 weeks.

• Proportion of missing data in self-report outcome questionnaires.

  Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).

  12 weeks.

• Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (EQ-5D-5L).

  Descriptive statistics of returned EQ-5D-5L questionnaires. The standardised EQ-5D-5L measures health outcomes through a descriptive profile and a visual analogue scale (VAS). The descriptive profile encompasses 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').

  12 weeks

• Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (FACT-B).

  Descriptive statistics of returned FACT-B questionnaires.

  12 weeks

• Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (B-CBI).

  Descriptive statistics of returned B-CBI questionnaires. The 12-item questionnaire Cancer Behaviour Inventory - brief version measures patients' self-efficacy for coping with cancer by asking them to rate their confidence to perform certain behaviours on a scale of 1 (not at all confident) to 9 (totally confident). CBI-B is a single score measure (minimum score = 12, maximum score = 108) with higher scores indicative of greater self-efficacy.

  12 weeks

• Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (SEMCD-6).

  Descriptive statistics of returned SEMCD-6 questionnaires. This 6-item SEMCD-6 measures self-efficacy to manage chronic disease, asking patients to rate their confidence in their abilities to perform a range of self-management tasks. Each of the 6 items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores for the scale are calculated as a mean of the 6 items (minimum score = 1, maximum score = 10), with higher scores indicating greater self-efficacy.

  12 weeks

• Acceptability & use of intervention: Number of symptom monitoring reports generated and qualitative interview data.

  Number of symptom monitoring reports generated and qualitative interview data.

  12 weeks

Secondary Outcomes (4)

• Estimation of effect size for QOL using participant scores for EQ-5D-5L.

  12 weeks

• Estimation of effect size for QOL using participant scores for FACT-B.

  12 weeks

• Estimation of effect size for self-efficacy using participant scores for B-CBI.

  12 weeks

• Estimation of effect size for self-efficacy using participant scores for SEMCD-6.

  12 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

12 weeks access to LIBERATE online supportive intervention (dose not specified) including symptom monitoring questionnaire component, with questionnaire results integrated within electronic medical records for clinician review.

Other: LIBERATE website

Waiting list control arm

NO INTERVENTION

Care and support as usual; no access to intervention. Placed on waiting list to receive intervention following study completion.

Interventions

LIBERATE website OTHER

The LIBERATE intervention is a self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Components include; holistic health information specific to secondary breast cancer, symptom monitoring and self-management advice, case studies, signposting to services \& support and support for family \& loved ones.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leeds: lead
• Breast Cancer Now: collaborator

Study Sites (1)

St James University Hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Psychosocial Medical Oncology

Model Details: Parallel group, two-arm randomised model using a waiting list control design. \[A separate single arm study (non-randomised, pre-post design) will run in parallel, recruiting via online channels.\]

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 22, 2019
• Study Start: June 6, 2020
• Primary Completion: January 11, 2021
• Study Completion: March 31, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

GB (1)