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Original research
Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods
  1. Catherine Sandsund1,
  2. Richard Towers2,
  3. Karen Thomas3,
  4. Ruth Tigue1,
  5. Amyn Lalji1,
  6. Andreia Fernandes4,
  7. Natalie Doyle5,
  8. Jake Jordan6,
  9. Heather Gage6 and
  10. Clare Shaw1
  1. 1 Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK
  2. 2 Lead Nurse Counsellor, Psychological Support Services, The Royal Marsden NHS Foundation Trust, London, UK
  3. 3 Senior Statistician Research Data Management and Statistics Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK
  4. 4 Gynaeoncology Unit, Clinical Services Division, The Royal Marsden NHS Foundation Trust, London, UK
  5. 5 Nurse Consultant in Living With and Beyond Cancer, The Royal Marsden NHS Foundation Trust, London, UK
  6. 6 Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK
  1. Correspondence to Catherine Sandsund, Therapies Department, The Royal Marsden NHS Foundation Trust, London, SW3 6JJ, UK; catherine.sandsund{at}rmh.nhs.uk

Abstract

Objectives Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I–III gynaecological cancer.

Methods Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview.

Results 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold.

Conclusion Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I–III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.

  • gynaecological cancer
  • care plans
  • holistic needs assessment
  • quality of life
  • cost effectiveness
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjspcare-2016-001207

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    Footnotes

    • Contributors This work was undertaken as a collaborative clinical research project. The contributions of the authors are outlined below. Study design: CAS, CS, RT, ND, AF and HG (additional contributions from patient representatives, therapies department, psychological support services and the gynaeocology clinical nurse specialists). Patient information sheet, consent form, study poster design: CAS, CS and patient representatives. Recruitment: CAS and RCT. Interventions: CAS and RCT. Semi-structured interviews: Kath Malhotra, RCT. Data management: AL. Statistical analysis: KT. Health economics analysis: HG and JJ. Interview analysis: RT and CAS. Manuscript preparations: CAS, CS, JJ, KT, RT, HG, RCT, ND, AF and patient representative (NH).

    • Funding This study was funded by the Royal Marsden Charity.The study is reported according to CONSORT guidelines extension for non-pharmacological treatments.

    • Competing interests None declared.

    • Patient consent No individuals' identifiable information is included in this paper.

    • Ethics approval National Research Ethics Committee London – West London.

    • Provenance and peer review Not commissioned; externally peer reviewed.