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

Abstract

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.

Figure 1

PeNTAGOn study design: a randomised controlled trial. Schematic diagram of the PeNTAGOn study design. Patients will be screened for eligibility (criteria listed), then approached and randomised to receive usual care or usual care with the nurse and telephone peer support intervention. Critical intervention time-points are highlighted pre-, mid-, end- and post-treatment. Time-points for follow-up data collection to 12 months post end of radiotherapy are noted. Estimates for sample recruitment and retention are shown in each step of the diagram. Box 1 describes baseline data collected. Box 2 describes key features of the intervention. Boxes 3 to 7 describe follow-up data collection. AQ, Adherence questionnaire; CaTS, Cancer Treatment Survey; FACT-G, Functional Assessment for Cancer Therapy - General; GC, Gynaecological cancer; HADS, Hospital Anxiety and Depression Scale; LENT SOMA, Late Effects of Normal Tissues / Subjective-Objective Management Analytic; MSAS-SF, Memorial Symptom Assessment Scale Short Form; RT, Radiotherapy; SCNS-SF, Supportive Care Needs Survey - Short Form; SVQ, Sexual function-vaginal changes questionnaire.