A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial

Trials

Sanchia Aranda³  Sylvia Penberthy⁵  David Bernshaw⁶  Kate White²  Meinir Krishnasamy¹  Linda Mileshkin⁶  Karla Gough⁵  Rebecca Bergin⁵  Ilona Juraskova⁴  Penelope Schofield¹ 

[1] School of Health Sciences, Department of Nursing, The University of Melbourne, 3010, Parkville, Vic, Australia;Sydney Cancer Centre, Royal Prince Alfred Hospital, 2050, Camperdown, NSW, Australia;Cancer Institute NSW, PO Box 41, 1435, Alexandria, NSW, Australia;Centre for Medical Psychology & Evidence-based Decision making, University of Sydney, 2006, Sydney, NSW, Australia;Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, 3002, East Melbourne, Vic, Australia;Department of Gynaecological Oncology, Peter MacCallum Cancer Centre, 3002, East Melbourne, Vic, Australia

关键词: Psychosexual function;    Quality of life;    Distress;    Radiotherapy;    Gynaecological cancer;    RCT;    Intervention;    Nurse;    Peer support;   

Others  :  1094803
DOI  :  10.1186/1745-6215-14-39

 received in 2012-08-16, accepted in 2013-01-15,  发布年份 2013

【 摘 要 】

Background

Women who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women’s informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis.

Methods/design

This multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy.

Discussion

This timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated.

Trial registration

Australian New Zealand Clinical Trial Registry ACTRN12611000744954

【 授权许可】

   
2013 Schofield et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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