Condition category
Cancer
Date applied
13/06/2016
Date assigned
29/06/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation.

Trial website

Contact information

Type

Public

Primary contact

Dr Diane Roberts

ORCID ID

http://orcid.org/0000-0003-0264-921X

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30442

Study information

Scientific title

PACT: Peer support to maintain psychological wellbeing in people with advanced cancer. A feasibility study for a Randomised Controlled Trial (V1)

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

Wales Research Ethics Committee 5 Bangor, 03/02/2016, ref: 16/WA/0032

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

11/12/2015

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

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 type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

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

30/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Christie NHS Foundation Trust
Oncology Unit Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

Clatterbridge Cancer Centre NHS Foundation Trust
Clatterbridge Health Park Clatterbridge Road
Wirral
CH63 4JY
United Kingdom

Sponsor information

Organisation

Lancaster University

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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

Intention to publish date

30/11/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.