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Trial registered on ANZCTR


Registration number
ACTRN12611000744954
Ethics application status
Approved
Date submitted
14/07/2011
Date registered
15/07/2011
Date last updated
16/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
PeNTAGOn: Peer & Nurse support Trial to Assist women in Gynaecological Oncology
Scientific title
A nurse led psychosocial intervention with peer support to reduce needs in women being treated with radiotherapy for gynaecological cancer: A RCT
Secondary ID [1] 262634 0
NHMRC Project Grant Application Number: 1005708
Universal Trial Number (UTN)
Trial acronym
PeNTAGOn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress in women who receive radiation therapy for Gynaecological Cancer 268335 0
Psychosocial needs of women who receive radiation therapy for Gynaecological Cancer 268337 0
Psychosexual difficulties that occur in women who receive Radiation therapy for Gynaecological Cancer 268338 0
Symptom distress among women who receive Radiation therapy for Gynaecological Cancer 268339 0
Quality of Life changes in women who receive Radiation therapy for Gynaecological Cancer 268340 0
How prepared women are for Radiation therapy treatment for Gynaecological Cancer 268342 0
Vaginal stenosis which occurs as a result of Radiation therapy for Gynaecological Cancer 268343 0
Condition category
Condition code
Cancer 268469 268469 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266981 0
Other interventions
Comparator / control treatment
The control group will receive standard care for women receiving radiotherapy for gynaecological cancer. This usually involves regular assessments by nurse and/or radiation oncologist throughout treatment.
Control group
Active

Outcomes
Primary outcome [1] 269219 0
Primary endpoint: Compared to the usual care group, the intervention group will report lower psychological distress.

Psychological distress will be assessed with the 14-item Hospital Anxiety and Depression Scale total scale (HADS-T) in a Questionnaire. Rasch analysis shows that items comprising the HADS-T form a unidimensional construct of psychological distress. It has demonstrated high internal consistency (alpha=0.82 to 0.90) in patient populations including cancer patients and responsiveness in psychosocial intervention studies.
Timepoint [1] 269219 0
From baseline to follow-up at a) pre-treatment and b) 4 weeks, 6 and 12 months post-treatment.
Secondary outcome [1] 279144 0
Secondary endpoints: Compared to the usual care group, the intervention group will experience:
i) Lower informational and psychosocial supportive care needs and lower symptom distress.

The 34 item Supportive Care Needs Survey-short form (SCNS-SF) in a Questionnaire covers unmet needs from five domains: psychological; health system and information; physical and daily living; patient care and support; and sexuality. All domain subscales have high internal consistency (alpha=0.87) and good divergent and convergent validity. PI Schofield found this scale to be responsive to change in a recent RCT with cancer patients.

Symptom distress will be measured with the 32 item Memorial Symptom Assessment Scale Short Form (MSAS-SF) comprising three subscales (physical, psychological and global distress) and a total symptom distress scale. All scales have demonstrated high internal consistency (alpha=0.76 to 0.87), good convergent validity (r =-0.68 to -0.74), excellent discriminative validity based on known groups comparisons and sensitivity to change in a longitudinal setting.
Timepoint [1] 279144 0
From baseline to follow-up at 4 weeks post-treatment.
Secondary outcome [2] 279145 0
ii) Better preparation for treatment

Cancer treatment-related information and support needs will be assessed by Questionnaire with the 25-item Cancer Treatment Survey (CaTS) which comprises two subscales for specific information and support needs domains: sensory-psychological concerns and procedural concerns. Both subscales have demonstrated high internal consistency (alpha>0.90) and good divergent validity (with HADS: r<0.26). Both were sensitive to change in PI Schofield's recent RCT.
Timepoint [2] 279145 0
From baseline to pre-treatment follow-up
Secondary outcome [3] 279146 0
iii) Lower informational and psychological supportive care needs and psychosexual difficulties

The 34 item Supportive Care Needs Survey-short form (SCNS-SF) in a Questionnaire covers unmet needs from five domains: psychological; health system and information; physical and daily living; patient care and support; and sexuality. All domain subscales have high internal consistency (alpha=0.87) and good divergent and convergent validity. PI Schofield found this scale to be responsive to change in a recent RCT with cancer patients.

Self-report Sexual function and vaginal changes will be assessed with the 27-item Sexual function-Vaginal changes Questionnaire (SVQ) Questionnaire, developed for gynaecological cancer, comprising three scales for all patients (intimacy, sexual interest and global sexual satisfaction) and two scales for sexually active respondents (vaginal changes and sexual functioning). All five scales have demonstrated high internal consistency (alpha =0.76 to 0.83) and sensitivity to change longitudinally.
Timepoint [3] 279146 0
From baseline to follow-up at 6 and 12 months post-treatment.
Secondary outcome [4] 279147 0
iv) Higher quality of life

Cancer-specific Quality of Life will be assessed with the 27-item Functional Assessment for Cancer Therapy - General (FACT-G) Questionnaire. The FACT-G comprises four subscales for specific quality of life domains: physical well-being, social well-being, emotional well-being and functional well-being. Its scaling and unidimensionality of subscales have been confirmed by factor and Rasch analyses. All subscales have demonstrated high internal consistency (alpha=0.72 to 0.90), good convergent (r>0.51), divergent (r<0.22) and discriminative validity in cancer patients and responsiveness in psychosocial intervention studies.
Timepoint [4] 279147 0
From baseline to follow-up at 4 weeks, 6 and 12 months post-treatment
Secondary outcome [5] 279148 0
v) Less vaginal stenosis

The participant's treating clinician will conduct a clinical vaginal examination. The LENT SOMA scale, objective criteria for vaginal/sexual dysfunction, will be used to measure vaginal changes.

A purpose designed patient self-report Adherence Questionnaire (AQ) will assess adherence to the use of vaginal dilators/cylinders, moisturisers, lubricants and pelvic floor exercises.
Timepoint [5] 279148 0
Clinical assessments at 3, 6 and 12 months post-treatment.

Patient self-report AQ at 6 and 12 months post-treatment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clinician will identify patients who are capable of understanding the study and giving informed consent before approaching them about the study, based on their experience in treating them. The clinician will introduce the study to potential participants. If interested, they will be referred to the data manager who will provide them with the information sheet and consent form. The data manager will further answer any questions the patient may have, and clarify that the patient understands the study and that is it optional, before obtaining consent. The participant will give written consent using the form provided.

Site data managers will fax consenter & decliner (non-consenter) details to the central site. Central randomisation will be made by computer to either the intervention or usual care arms.

To assess for consent bias, non-consenters will be asked if de-identified basic demographic and medical details can be noted. Attrition will be monitored and reasons for withdrawal will be recorded in each arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A consecutive sample of consenting patients will be randomised 1:1. Participants will be stratified according to treating hospital, and treatment type: external beam radiotherapy (with or without brachytherapy); or external beam radiotherapy (with or without brachytherapy) plus chemotherapy; or brachythearpy alone. Minimisation will be used to balance the randomisation across the strata. Randomisation will be remotely and independently performed at Peter MacCallum Cancer Centre. The method of randomisation will be by a weighted-biased coin method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Those patients randomised to the control group will receive standard care as is usual for the study site. The trial adheres to CONSORT criteria and intervention procedures will be strictly monitored for protocol adherence. All other conditions between the two arms will be equivalent. Reasons for attrition will be recorded, and recruitment and dropout bias assessed. Intention to treat analyses will be conducted. Blinding of patients and providers cannot be achieved with this study design. However, outcome assessment will be by self-reported questionnaire, thereby obviating the need for researcher blinding.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2010
Actual
28/09/2010
Date of last participant enrolment
Anticipated
Actual
19/08/2015
Date of last data collection
Anticipated
Actual
2/11/2016
Sample size
Target
318
Accrual to date
Final
318
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 1710 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 1711 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 1712 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 1713 0
Westmead Hospital - Westmead
Recruitment hospital [5] 1714 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 1715 0
Royal Hospital for Women - Randwick
Recruitment hospital [7] 1716 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 4415 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 4242 0
3000
Recruitment postcode(s) [2] 4243 0
2000
Recruitment postcode(s) [3] 4244 0
4000
Recruitment postcode(s) [4] 10628 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 267455 0
Government body
Name [1] 267455 0
NHMRC
Country [1] 267455 0
Australia
Primary sponsor type
Individual
Name
Prof Penelope Schofield
Address
Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Country
Australia
Secondary sponsor category [1] 266500 0
None
Name [1] 266500 0
Address [1] 266500 0
Country [1] 266500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269428 0
Peter MacCallum Cancer Centre Clinical Research Committee (CRC) and Human Research Ethics Committee (HREC)
Ethics committee address [1] 269428 0
Ethics committee country [1] 269428 0
Date submitted for ethics approval [1] 269428 0
Approval date [1] 269428 0
19/05/2009
Ethics approval number [1] 269428 0
ID:09/07
Ethics committee name [2] 269429 0
Sydney Local Health District (RPAH Zone)
Ethics committee address [2] 269429 0
Ethics committee country [2] 269429 0
Australia
Date submitted for ethics approval [2] 269429 0
Approval date [2] 269429 0
04/05/2011
Ethics approval number [2] 269429 0
X11-0112
Ethics committee name [3] 269430 0
Royal Brisbane and Women's Hospital
Ethics committee address [3] 269430 0
Ethics committee country [3] 269430 0
Australia
Date submitted for ethics approval [3] 269430 0
24/05/2011
Approval date [3] 269430 0
09/08/2011
Ethics approval number [3] 269430 0
HREC/11/QRBW/202

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32881 0
Prof Penelope Schofield
Address 32881 0
Swinburne University
Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Country 32881 0
Australia
Phone 32881 0
+61 3 9214 4886 (Mon, Wed, Frid)
Fax 32881 0
Email 32881 0
[email protected]
Contact person for public queries
Name 16128 0
Penelope Schofield
Address 16128 0
Swinburne University
Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Country 16128 0
Australia
Phone 16128 0
+61 3 9214 4886 (Mon, Wed, Frid)
Fax 16128 0
Email 16128 0
[email protected]
Contact person for scientific queries
Name 7056 0
Penelope Schofield
Address 7056 0
Swinburne University
Department of Psychological Sciences
School of Health Sciences | Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122 | Internal Mail H24
Country 7056 0
Australia
Phone 7056 0
+61 3 9214 4886 (Mon, Wed, Frid)
Fax 7056 0
Email 7056 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA nurse- and peer-led psycho-educational intervention to support women with gynaecological cancers receiving curative radiotherapy: The PeNTAGOn randomised controlled trial - ANZGOG 1102.2020https://dx.doi.org/10.1016/j.ygyno.2020.09.016
EmbaseDifferential adherence to peer and nurse components of a supportive care package-The appeal of peer support may be related to women's health and psychological status.2022https://dx.doi.org/10.1016/j.pec.2021.06.020
N.B. These documents automatically identified may not have been verified by the study sponsor.