None listed
Conditions
Brief 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.
Interventions
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;
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.
Sponsors
Prof Penelope Schofield
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients will: 1) Have a confirmed diagnosis of gynaecological cancer; 2) be scheduled to receive radiotherapy with curative intent to the pelvis, 3) be aged 18 years or older, 4) be able to read and write English, and give informed consent.
Exclusion criteria
Exclusion criteria are: 1) a severe psychiatric or cognitive disorder, 2) treatment with palliative intent, 3) or previous treatment with radiotherapy to any part of the body.
Outcome results
None listed