Peer support to maintain psychological wellbeing in people with advanced cancer: A feasibility study

ISRCTN	ISRCTN10276684
DOI	https://doi.org/10.1186/ISRCTN10276684
Secondary identifying numbers	30442

Submission date: 13/06/2016
Registration date: 29/06/2016
Last edited: 14/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Diane Roberts
Public

University of Manchester
Room 5.305
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0003-0264-921X

Prof Catherine Walshe
Scientific

C052, C - Floor
Furness College
Lancaster University
Bailrigg
Lancaster
LA1 4YW
United Kingdom

Study information

Study design	Interventional; Design type: Prevention, Process of Care, Education or Self-Management, Psychological & Behavioural, Complex Intervention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	PACT: Peer support to maintain psychological wellbeing in people with advanced cancer. A feasibility study for a Randomised Controlled Trial (V1)
Study acronym	PACT
Study hypothesis	The aim of this study is to determine the feasibility of delivering and investigating a novel peer mentor intervention to promote and maintain psychological wellbeing in people with advanced cancer using a randomised controlled trial design.
Ethics approval(s)	Wales Research Ethics Committee 5 Bangor, 03/02/2016, ref: 16/WA/0032
Condition	Specialty: Cancer, Primary sub-specialty: Palliative and supportive care; UKCRC code/ Disease: Cancer/ Malignant neoplasms of ill-defined, secondary and unspecified sites
Intervention	Patients completing baseline assessment (T=0) will be allocated to either intervention or control group using a telephone system provided by Manchester Academic Health Science Centre Clinical Trials Unit (MAHSC-CTU). Carers will NOT be randomised independently but will be considered as belonging to intervention or control group according to the allocation of the associated patient. Intervention Group: Patients will be preference matched with a trained volunteer mentor for a period of 12 weeks during which time they will meet/communicate in various ways according to personal preference to facilitate peer learning of coping strategies. Patients will continue to receive ‘usual care’ i.e. all those therapies and clinical interventions/services which would be offered in the absence of the study intervention. Carers will not be actively involved in receipt of the intervention but will be assessed for indirect effects. Control group: Patients allocated to the control group will solely receive usual care for the 12 weeks of the study. Participants in both groups are followed up after 4 and 12 weeks. Additionally, a sub-group of participants from each category (patient, carer, mentor or health professional) will be interviewed at baseline and 12 weeks (or earlier exit from the study).
Intervention type	Behavioural
Primary outcome measure	Patient and carer psychological wellbeing is measured using the WHO Quality of Life-BREF questionnaire (WHOQOL-BREF) at baseline, 4 and 12 weeks.
Secondary outcome measures	1. Patient and carer psychological wellbeing (WHOQOL-BREF) at T = 12 weeks (or completion of intervention if before 12 weeks). 2. Patient health related quality of life is measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ C 15 PAL) at baseline, 4 and 12 weeks (or completion of intervention if before 12 weeks) 3. Patient and carer coping strategies is measured using the Brief Coping Orientation for Problems Experienced (Brief COPE) questionnaire at baseline, 4 and 12 weeks (or completion of intervention if before 12 weeks) 4. Patient depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, 4 and 12 weeks (or completion of intervention if before 12 weeks) 5. Social Support is measured using the modified Medical Outcomes Study Social Support Survey (mMOS-SS) in patient participants, and the Carer Support Needs Assessment Tool (CSNAT) questionnaire in carer participants) at baseline, 4 and 12 weeks (or completion of intervention if before 12 weeks)
Overall study start date	11/12/2015
Overall study end date	30/11/2018

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	16 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment	30
Participant inclusion criteria	Patient inclusion criteria: 1. Aged 16 years and over 2. With advanced cancer (any type), defined as metastatic disease at diagnosis, and/or with local or metastatic spread following treatment and/or where prognosis is estimated as less than a year. Those whom their health care professionals judge to have a prognosis > 3 months to facilitate study completion. 3. Those whom their health care professionals judge have capacity to give informed consent to research participation. 4. Assessed by their health care professional as understanding their diagnosis of advanced cancer. 5. Able to adequately understand and respond to verbal and written material in English. Peer Mentor inclusion criteria: 1. Experience of living with cancer 2. At least six months post diagnosis 3. Aged 18 years and over 4. Able to commit to six months of volunteering 5. Have at least two hours per week available for volunteering 6. Live in the geographic area selected for the project 7. Fluency in written and spoken English 8. Qualitative demonstration of empathy, compassion, and open and non-didactic communication skills 9. Satisfactory completion of project-specific training (assessed by research team) 10. DBS clearance for working with vulnerable people. Carer and Professional Participants: Recruited patients will be asked to nominate one “person they get most support from”, and an invitation to participate sent to this identified carer. In addition, patient participants will nominate one healthcare professional providing cancer and/or palliative care to them on a regular basis, and an invitation to participate will be sent to this identified healthcare professional.
Participant exclusion criteria	Patient criteria: 1. Aged under 16 years 2. With advanced cancer prognosis < 3 months 3. Those whom their health care professionals judge not to have capacity to give informed consent to research participation 4. Assessed by their health care professional as not understanding their diagnosis of advanced cancer Peer Mentor criteria: 1. No experience of living with cancer 2. Less than months post diagnosis 3. Aged under 18 years 4. Unable to commit to six months of volunteering 5. ave less than two hours per week available for volunteering 6. Live outside the geographic area selected for the project 7. No qualitative demonstration of empathy, compassion, and open and non-didactic communication skills 8. Unable to be granted DBS clearance for working with vulnerable people Carer Participants: 1. Aged under 18 years 2. Caring for someone with an advanced cancer prognosis < 3 months 3. Those whom patient's health care professionals judge not to have capacity to give informed consent to research participation 4. Assessed by the patient's health care professional as not understanding the associated patient's diagnosis of advanced cancer Professional Participants: No exclusion criteria
Recruitment start date	01/08/2016
Recruitment end date	01/04/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

The Christie NHS Foundation Trust

Oncology Unit
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Clatterbridge Cancer Centre NHS Foundation Trust

Clatterbridge Health Park
Clatterbridge Road
Wirral
CH63 4JY
United Kingdom

Sponsor information

Lancaster University
University/education

Research Support Office
B58
Bowland Main
Lancaster
LA1 4YW
England
United Kingdom

"ROR"	https://ror.org/04f2nsd36

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/11/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	1. Planned publication of articles covering several aspects of the study including mentor training and design 2. Planned dissemination of results through professional and academic conferences or similar routes
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2020	12/05/2020	Yes	No
Results article	results	17/08/2020	21/08/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

14/09/2022: Internal review.
21/08/2020: Publication reference added.
12/05/2020: Publication reference added.
08/11/2019: Internal review.
16/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2017 to 01/04/2018.
2. Total final enrolment number added.
05/08/2019: Internal review.
21/06/2019: Internal review.
05/04/2019: Internal review.
05/03/2019: Internal review.
07/06/2018: Internal review.
14/05/2018: Internal review.
16/01/2018: Internal review.
16/10/2017: Internal review.
15/09/2017: Internal review.