Holistic needs assessment and care plans for women with gynaecological cancer – do they improve cancer specific health related quality of life? A mixed-methods study

Abstract

Background: Cancer and its treatment have lasting consequences for some. In the UK as part of a broader Recovery Package, the holistic needs assessment (HNA) and care planning is proposed to address unmet needs of people treated for cancer. The primary objective of this study was to test whether HNA and care planning by an allied health professional (AHP) improved cancer‐specific quality of life for women following curative treatment for stage I‐III gynaecological cancer. Secondary objectives compared changes between groups in functioning, symptoms, general self‐efficacy and generic health related QoL, evaluated the impact on health and social care provision, conducted a cost‐effectiveness analysis and explored the impact of HNA and care‐planning. Methods: Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs. usual care) at a UK cancer centre. Balancing factors were age, tumour site and primary treatment. Data were collected by questionnaire at baseline, three and six months. Women in the intervention group were offered consultations conducted using behavioural change principles with an AHP. Reviews were offered at three months. Outcomes were six‐month change in EORTC‐QLQ‐C30 global score (primary), and in EORTC sub‐scales, generic quality of life (SF‐36), self‐efficacy (General Self Efficacy Scale) (secondary outcomes). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and Quality Adjusted Life Years (from SF‐6) were gathered for a costeffectiveness analysis. Thematic analysis was used to interpret data from an exit interview. Results: 150 women consented (75 per group), ten completing the intervention undertook an interview. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary end‐point with a mean change in score favouring the control group of 1.5(95% CI ‐5.7, 8.7). The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to an improvement seen in EORTC functional and symptom scales. Themes from interview data were: dislocation: isolation, uncertainty and vulnerability at the end of treatment; space to be heard and understood by a 'trustworthy' independent professional; and moving towards to self‐supported management. Economic analysis suggests a 62% probability of cost‐effectiveness at a £30,000/QALY threshold. Conclusion: Care plan development using behavioural change principles, conducted by an AHP is cost‐effective, acceptable and useful for some women treated for stage I‐III gynaecological cancer. We suggest, on balance, this should be available for women following treatment and a similar approach tested earlier in the pathway.