CompletedPhase 3ACTRN12611000744954

PeNTAGOn: Peer & Nurse support Trial to Assist women in Gynaecological Oncology

A nurse led psychosocial intervention with peer support to reduce needs in women being treated with radiotherapy for gynaecological cancer: A RCT


Sponsor

Prof Penelope Schofield

Enrollment

318 participants

Start Date

Sep 28, 2010

Study Type

Interventional

Conditions

Summary

This study aims to reduce the emotional, psychosocial and physical needs of women being treated with radiotherapy for gynaecological cancer. We are investigating the benefits of a new program which combines specialist nurse consultations with telephone peer support before, during, and after treatment, compared to current standard care alone. Who is it for? Eligible patients for this trial are 18 years or older, have a confirmed diagnosis of gynaecological cancer, speak and read English, and are scheduled to receive radiotherapy with curative intent to the pelvis. Eligible peer support volunteers are women who are 18 years or older, have received radiotherapy to the pelvis for a gynaecological cancer at least 2years ago, and can speak and read English. Trial details: In this study, patients will be randomly allocated to either standard care currently offered at their hospital, or to standard care PLUS the trial support program involving nurse-led consultations and telephone peer support. The consultations and telephone support will focus on the physical, functional, psychological, sexual, informational and social needs of patients at four time-points: pre-treatment, mid-treatment, at the end of treatment, and post-treatment. Patients randomly allocated to the new program will have a nurse consultation (face-to-face or over the phone) and peer support telephone call at each of these time-points. All participants will complete 5 surveys over 14 months, so we can assess whether the new program improves patient outcomes. The first ACTRN relevant to this study is for the initial development & pilot testing phase: ACTRN12609000312246. A second ACTRN is for the phase III trial for which this study was the initial development & pilot testing phase has also been submitted: ACTRN12611000744954.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether peer support and specialized nursing care can improve well-being and reduce distress in women aged 18 and older who have been diagnosed with gynaecological cancer and are scheduled to receive pelvic radiation therapy with curative intent. Participants must be able to read and write English and provide informed consent. The study aims to determine if combined peer and nurse support leads to better emotional and physical outcomes during treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention involves two synergistic elements: 1. nurse-led consultations and 2. telephone peer support. The intervention addresses key physical, functional, psychological, sexual, informatio

The intervention involves two synergistic elements: 1. nurse-led consultations and 2. telephone peer support. The intervention addresses key physical, functional, psychological, sexual, informational and social needs of patients receiving radiotherapy, as prescribed by their clinician, that arise at four critical points in the illness trajectory: (a) Pre- treatment (Contact 1: Nurse-face to face - 1hour, or phone; Peer-phone - 30mins) (b) Mid- treatment (Contact 2: Nurse-face to face - 30mins; Peer-phone - 30mins) (c) End of treatment (Contact 3: Nurse-face to face - 30mins; Peer-phone - 30mins) (d) Post-treatment (Contact 4: Nurse-phone 2 weeks post-treatment - 30mins; Contact 5: Peer-phone 4 weeks post-treatment - 30mins). Note that patients receiving brachytherapy treatment alone who have a shorter length of treatment time may have nurse and peer contacts 2 and 3 combined. Each woman will be assigned a peer who will provide 3 or 4 telephone support sessions. Peers will be matched to the participant’s medical and personal circumstances. After nurse sessions 1 to 3, the peer will contact the patient one week after this contact with the nurse. In session 4, the peer will contact the patient at 4 weeks post-treatment. The nurse will provide the peer with a check list of the patient’s concerns and the individualised self-care plan. The patient can nominate particular concerns which she does not wish to discuss with her peer during the nurse consultation. Using a structured format, the peer’s role will be: (i) To provide psychosocial support to the patient, (ii) To encourage adherence to the recommended self-care strategies.


Locations(8)

Peter MacCallum Cancer Institute - East Melbourne

NSW,QLD,TAS,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,TAS,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,TAS,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,TAS,VIC, Australia

Prince of Wales Hospital - Randwick

NSW,QLD,TAS,VIC, Australia

Royal Hospital for Women - Randwick

NSW,QLD,TAS,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,TAS,VIC, Australia

Launceston General Hospital - Launceston

NSW,QLD,TAS,VIC, Australia

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ACTRN12611000744954