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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]

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

Psychosocial needs of women who receive radiation therapy for Gynaecological Cancer

Psychosexual difficulties that occur in women who receive Radiation therapy for Gynaecological Cancer

Symptom distress among women who receive Radiation therapy for Gynaecological Cancer

Quality of Life changes in women who receive Radiation therapy for Gynaecological Cancer

How prepared women are for Radiation therapy treatment for Gynaecological Cancer

Vaginal stenosis which occurs as a result of Radiation therapy for Gynaecological Cancer

Condition category

Condition code

Cancer

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]

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]

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]

From baseline to follow-up at a) pre-treatment and b) 4 weeks, 6 and 12 months post-treatment.

Secondary outcome [1]

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]

From baseline to follow-up at 4 weeks post-treatment.

Secondary outcome [2]

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]

From baseline to pre-treatment follow-up

Secondary outcome [3]

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]

From baseline to follow-up at 6 and 12 months post-treatment.

Secondary outcome [4]

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]

From baseline to follow-up at 4 weeks, 6 and 12 months post-treatment

Secondary outcome [5]

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]

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?

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]

Peter MacCallum Cancer Institute - East Melbourne

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [3]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [4]

Westmead Hospital - Westmead

Recruitment hospital [5]

Prince of Wales Hospital - Randwick

Recruitment hospital [6]

Royal Hospital for Women - Randwick

Recruitment hospital [7]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [8]

Launceston General Hospital - Launceston

Recruitment postcode(s) [1]

3000

Recruitment postcode(s) [2]

2000

Recruitment postcode(s) [3]

4000

Recruitment postcode(s) [4]

7250 - Launceston

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Level 1, 16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Clinical Research Committee (CRC) and Human Research Ethics Committee (HREC)

Ethics committee address [1]

Peter MacCallum Cancer Centre
10 St Andrews Place
East Melbourne 
VIC  3002

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

19/05/2009

Ethics approval number [1]

ID:09/07

Ethics committee name [2]

Sydney Local Health District (RPAH Zone)

Ethics committee address [2]

Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

04/05/2011

Ethics approval number [2]

X11-0112

Ethics committee name [3]

Royal Brisbane and Women's Hospital

Ethics committee address [3]

Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Qld, 4029

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

24/05/2011

Approval date [3]

09/08/2011

Ethics approval number [3]

HREC/11/QRBW/202

Summary

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.

Trial website

Trial related presentations / publications

Publications
Rebecca J. Bergin; Suzi M. Grogan; David Bernshaw; Ilona Juraskova; Sylvia O Penberthy; Linda R. Mileshkin; Meinir Krishnasamy; Alison C. Hocking; Sanchia K. Aranda; Penelope E. Schofield. Developing an evidence-based, nurse-led psycho-educational intervention with peer support in gynaecological oncology. Cancer Nursing: An International Journal for Cancer Care, 2015 (accepted for publication Feb 2015)

Schofield P, Juraskova I, Bergin R, Gough K, Mileshkin L, Krishnasamy M, White K, Bernshaw D, Penberthy S, Aranda S. A nurse and peer led support program to assist women in gynaecological oncology, the PeNTAGOn study (Peer and Nurse support Trial to Assist women in Gynaecological Oncology): protocol for a randomised controlled trial. Trials 2013, 14:39. DOI: 10.1186/1745-6215-14-39 (online publication, 11 February 2013).

Invited speaker
A/Prof Penny Schofield (invited keynote speaker presentation), ‘Sexuality in survivorship: how do we design effective and sustainable interventions?’ 12th Acta Oncologica Symposium: European Cancer Rehabilitation & Survivorship Symposium 2014. Copenhagen, Sept 7 – 9, 2014

A/Prof Penny Schofield (1-day workshop facilitator), ‘Discussing sexuality with people diagnosed with cancer’, 12th Acta Oncologica Symposium: European Cancer Rehabilitation & Survivorship Symposium 2014. Copenhagen, Sept 7, 2014


Conference—edited volume of conference proceedings 
Ben Huntingdon (Poster presentation), Ilona Juraskova, Zahava Wolfowicz, Rebecca Bergin, Donna Kabel, Jennifer Edmunds, Sylvia Penberthy, Penelope Schofield, “Should we protocolise peer support programs in Oncology? A qualitative insight into the experiences of gynaecological cancer survivors delivering protocolised peer support”, 2013 Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting – Adelaide, AUSTRALIA.


Conference - invited speaker: 
Penelope Schofield (invited speaker), Rebecca Bergin, Ilona Juraskova, Suzi Grogan, Kate White, Stella Bu, Annette Beattie, Meinir Krishnasamy, Alison Hocking, Sylvia Penberthy, Taryn Robinson, David Bernshaw, Linda Mileshkin, Sanchia Aranda, “Intensive training methods for peer volunteers who deliver a complex, psychosocial intervention in a Phase III trial: PeNTAGOn.” 2012 International Psycho-Oncology Society 14th World Congress, Brisbane, AUSTRALIA

Conference—edited volume of conference proceedings: 

Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw B, Aranda S, Schofield P (Oral presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 OZPOS/PoCoG Psycho-oncology Professional Day, Clinical Oncological Society of Australia (COSA) - Melbourne AUSTRALIA. 
Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw B, Aranda S, Schofield P (Poster presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 Clinical Oncological Society of Australia (COSA) - Melbourne AUSTRALIA. 
Hocking, A., Robinson, T., Mileshkin, L., Juraskova, I., Bonner, C., Annab, R., Sharkey, K., Bergin, R., Krishnasamy, M., Bernshaw, D., Aranda, S. & Schofield, P. (Poster Presentation): ‘Audit of usual care provided at Australian radiotherapy treatment centres for women with gynaecological cancer (GC)’, 2010 Clinical Oncological Society of Australia (COSA), Annual Scientific Meeting – Melbourne AUSTRALIA. Juraskova I, Bergin R, Grogan S, Sharkey K, Mileshkin L, 
Krishnasamy M, Hocking A, Bernshaw D, Aranda S and Schofield P (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 13th Biennial Meeting of the International Gynecological Cancer Society (IGCS) - Prague CZECH REPUBLIC. 
Schofield P, Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer’, 2010 European Association Communication in Healthcare conference - Verona, ITALY.

Conference—unpublished presentation: 
Mileshkin L, (Presentation – New concept update) ‘Progress update and future plans for the research project: A nurse led psychosocial intervention with peer support to reduce psychosocial needs in women with gynaecological cancer’, 2009 Australian New Zealand Gynaecological Oncology Group (ANZGOG) General and Business Meeting – Gold Coast AUSTRALIA 
Schofield P Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women undergoing radiotherapy for gynaecological cancer (GC)’, 2010 Beyond Blue Research Forum – Melbourne AUSTRALIA. 
Schofield P, (Presentation – Clinical Trial Concept Session) ‘An innovative psychosocial intervention for women with gynaecological cancer’, 2009 Australian New Zealand Gynaecological Oncology Group (ANZGOG)/ Australian Society of Gynaecologic Oncologists (ASGO) inaugural joint conference – Noosa AUSTRALIA. 
Schofield P, Bergin R, Grogan S, Sharkey K, Juraskova I, Mileshkin L, Krishnasamy M, Hocking A, Bernshaw D and Aranda S (Poster Presentation): ‘The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)’, 2010 Australian New Zealand Gynaecological Oncology Group (ANZGOG) annual scientific meeting – Noosa AUSTRALIA. 
Schofield P, (Presentation – Trials update) ‘PeNTAGOn: Peer and Nurse support Trial to Assist women in Gynaecological Oncology - ANZGOG AGM update’, 2011 Australian New Zealand Gynaecological Oncology Group (ANZGOG) Annual Scientific Meeting – Noosa 
Schofield P, (Presentation) Ilona Juraskova, Rebecca Bergin, Trish Waters, Suzi Grogan, Kate White, Stella Bu, Annette Beattie, Rachel Murray, Meinir Krishnasamy, Alison Hocking, Taryn Robinson, Sanchia Aranda, ‘Intensive training methods for Nurses and Peer volunteers who deliver a complex, psychosocial intervention in a Phase III trial.’ 2012 CNSA Gynaecological Oncology Special Interest Nurses Group forum, ANZGOG Scientific meeting – Gold Coast, AUSTRALIA, 22-24/02/2012.

Taryn Robinson (Poster Pesentation) ‘Audit of usual care provided at Australian radiotherapy centres for women with gynaecological cancer.’ 2012 Australian New Zealand Gynaecological Oncology Group (ANZGOG) Annual Scientific Meeting – Gold Coast, AUSTRALIA 22-24/02/2012.

Schofield P, (Presentation – Trials update) ‘PeNTAGOn: Peer and Nurse support Trial to Assist women in Gynaecological Oncology - ANZGOG AGM update’, 2012 Australian New Zealand Gynaecological Oncology Group (ANZGOG) Annual General Meeting – Gold Coast, AUSTRALIA 22 - 25/02/2012.
Linda Mileshkin, (Presentation) “Patient Reported Outcomes: PeNTAGOn” Survivorship Workshop: Survivorship research in Gynaecological Cancer in Australia Saturday, 30th June 2012, Stamford Plaza, Sydney Airport. 

Rebecca Bergin, (Presentation) Ilona Juraskova, Suzi Grogan, Kate White, Stella Bu, Annette Beattie, Meinir Krishnasamy, Alison Hocking, Sylvia Penberthy, Taryn Robinson, David Bernshaw, Linda Mileshkin, Sanchia Aranda, Penelope Schofield “Intensive training methods for Nurses and Peer volunteers who deliver a complex, psychosocial intervention in a Phase III trial.” VCCC Endometrial and Cervical Symposium, Melbourne AUSTRALIA, 17 Aug 2012.

Public notes

Contacts

Principal investigator

Name

Prof Penelope Schofield

Address

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

Australia

Phone

+61 3 9214 4886 (Mon, Wed, Frid)

Fax

pschofield@swin.edu.au

Contact person for public queries

Name

Penelope Schofield

Address

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

Australia

Phone

+61 3 9214 4886 (Mon, Wed, Frid)

Fax

pschofield@swin.edu.au

Contact person for scientific queries

Name

Penelope Schofield

Address

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

Australia

Phone

+61 3 9214 4886 (Mon, Wed, Frid)

Fax

pschofield@swin.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A nurse- and peer-led psycho-educational intervention to support women with gynaecological cancers receiving curative radiotherapy: The PeNTAGOn randomised controlled trial - ANZGOG 1102.	2020	https://dx.doi.org/10.1016/j.ygyno.2020.09.016
Embase	Differential 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.	2022	https://dx.doi.org/10.1016/j.pec.2021.06.020

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