Finding My Way-Advanced: Can a web-based psychosocial intervention improve mental quality of life for women with metastatic breast cancer?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: The intervention consists of the Finding My Way ‐ Advanced web‐based psychological intervention. This consists of six modules, each consisting of three main components: (1) psychoeducation/information, (2) interactive empirically‐supported cognitive‐behavioural and mindfulness‐based worksheets/strategies, including: worksheets, quizzes, detached mindfulness, relaxation, acceptance of emotions, assertive communication, values clarification, and goal setting; and (3) testimonials of women with advanced breast cancer (ABC). Content is provided in a multimedia format, including text, graphics, audio‐clips (mindfulness and relaxation), and video (testimonials; psychoeducation/information clips from health professionals). Each of the six modules focuses on a different topic, namely (1) Navigating healthcare and making decisions; (2) Living well with a progressing illness (managing fear of progression and coping with uncertainty); (3) Managing physical symptoms (particularly focusing on fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role changes; and (6) Social support: receiving support and supporting family. The intervention is delivered individually and entirely online. While the intervention is co‐designed by cancer consumers, advocates, and health professionals, and registration is facilitated by the project coordinator as needed, the intervention is self‐guided. Based on pilot feedback and the adult learning literature, after viewing an introductory video and 'how to use' tutorial, all six modules will be immediately accessible; with weekly reminder emails/text messages released to participants to encourage engagement. Each module is anticipated to take approximately one hour in total to complete; however participants may lo CONDITION: Cancer ‐ Breast Mental Health ‐ Other mental health disorders metastatic breast cancer;Reduced mental quality of life; ; metastatic breast cancer ; Reduced mental quality of life PRIMARY OUTCOME: mean Mental Quality of Life (QoL), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ‐C30) emotional functioning subscale.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.; Primary timepoint: 6 weeks after intervention commencement ('post‐intervention')] ; [Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Social QOL, measured by the EORTC QLQ‐C30 social functioning subscale. INCLUSION CRITERIA: (1) Women with a diagnosis of MBC; (2) aged 18 years or older, (3) life expectancy of over 6 months (clinician’s judgement), and (4) sufficient English‐fluency for informed consent and program comprehension SECONDARY OUTCOME: Health Service Utilisation: centralised costing data from public hospitals (Australian Refined Diagnosis Related Groups (AR‐DRGs) will be accessed to determine the number and costs of public hospital inpatient episodes (which includes emergency department visits).[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: MBS data will be accessed to determine the number and costs of investigations,[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: MBS data will be accessed to determine the number and costs of medical treatments.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: MBS data will be accessed to determine the number and costs of out‐of‐hospital visits.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: Medicare Benefits Schedule (MBS) data will be accessed to determine the number and costs of medical consultations.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: Medicare Benefits Schedule (MBS) data will be accessed to determine the number and costs of primary care visits.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Health Service Utilisation: Pharmaceutical Benefits Scheme (PBS) data will be used to estimate quantity and costs of pharmaceuticals.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Cognitive QOL, measured by the EORTC QLQ‐C30 cognitive functioning subscale.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Fear of Progression, measured by the English‐version of the 12‐item Fear of Progression Questionnaire short form (FoP‐Q‐SF).[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean global QOL, assessed by the EORTC QLQ‐C30 global QOL subscale.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Physical QOL, measured by the EORTC QLQ‐C30 physical functioning subscale.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Psychological distress, measured by the 21‐item Depression Anxiety Stress Scale (DASS). Assesses anxiety, depression and stress over the previous week; total distress score will be used.[Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Role functioning QOL, measured by the EORTC QLQ‐C30 role functioning subscale. ; [Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] mean Unmet Needs, measured with the 34‐item Supportive Care Needs Survey–Short Form (SCNS‐SF). Measures perceived psychosocial, information, physical/activity of daily living, patient care and sexuality needs. Total scale score will be utilised. [Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.] Quality of life assessed using the EuroQol 5 dimensions 5 level (EQ‐5D‐5L). [Timepoints: baseline (pre‐intervention); 6 weeks post‐intervention commencement; 3‐months post‐intervention completion; 6 months post‐intervention completion.]
Epistemonikos ID: a55b44d99707297de089c11ffbaecb152d6da366
First added on: Aug 25, 2024