Condition category
Cancer
Date applied
06/11/2017
Date assigned
05/01/2018
Last edited
05/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to assess the perception of patients towards three different treatment options for the palliative treatment of cancer which has spread within the abdominal cavity (disseminated peritoneal adenocarcinoma). Adjuvant chemotherapy involves medication (chemotherapy) being given in addition to surgery in order to reduce the risk of the cancer coming back. Pressurised intra peritoneal aerosol chemotherapy (PIPAC) involves chemotherapy being sprayed in the abdomen, while hyperthermic intraperitoneal chemotherapy (HIPEC) involves heated chemotherapy treatment delivered directly to the abdomen. PIPAC is currently only able to be offered to patients in a limited feasibility capacity.

Who can participate?
Patients aged over 18 who are being treated with adjuvant chemotherapy, HIPEC or PIPAC for disseminated peritoneal adenocarcinoma

What does the study involve?
Participants are interviewed about their perspective and attitudes to the treatment option and their quality of life is assessed before treatment starts and for up to 3 months during treatment. Demographic data is collected from those patients who are offered PIPAC to determine if there are any factors associated with take up of the new treatment.

What are the possible benefits and risks of participating?
In order to allow future research and expansion of the treatment options available for patients, it is important to understand patients’ concerns, questions and expectations before and how they may change following treatment. This study will enable the development of patient information material for future studies and also to identify which patient groups (if any) are more or less likely to opt for new/innovative treatments.

Where is the study run from?
1. Cwm Taf University Health Board (UK)
2. Cardiff and Vale University Health Board (UK)

When is the study starting and how long is it expected to run for?
September 2017 to November 2018

Who is funding the study?
Tenovus (UK)

Who is the main contact?
Julie Cornish

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Julie Cornish

ORCID ID

Contact details

University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Patient Perspectives on Peritoneal Metastasis Treatments

Acronym

PerMeT

Study hypothesis

The trialists will approach all patients found to have intraperitoneal adenocarcinoma who are being considered for one of the three treatments (palliative chemotherapy, ePIPAC or HIPEC).
The aim of this study is to assess patient attitudes and perspectives on new innovations for cancer surgery before and after treatment. In addition information on key concerns of patients around each treatment option will be captured.

Ethics approval

Wales REC, 14/09/2017, ref: 17/WA/0247

Study design

Qualitative study

Primary study design

Observational

Secondary study design

Qualitative study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Adenocarcinoma with peritoneal metastases

Intervention

4-8 patients are recruited from each of the three treatment groups:
1. Adjuvant chemotherapy
2. HIPEC (hyperthermic intraperitoneal chemotherapy)
3. PIPAC

Over a 12-month period face to face interviews are performed and quality of life data are collected before treatment commences and for up to 3 months during treatment. Baseline demographic data of those patients being offered PIPAC are collected to determine if there are any associated factors with take up of the new treatment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Patient’s perspective and attitudes to the treatment option, assessed using qualitative interviews and focus groups at baseline and 3 months

Secondary outcome measures

1. Quality of life, measured using EQ5D
2. Personality profile of the patient and attitude of risk, assessed using Ten Item Personality inventory
3. Side effects experienced, assessed using patient diary and qualitative interviews
Measured at baseline and 3 months, with the patient diary also being assessed at 6 weeks

Overall trial start date

01/09/2017

Overall trial end date

01/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with disseminated peritoneal adenocarcinoma (of ovarian or colorectal origin)
2. Patients who are due to undergo treatment with; palliative chemotherapy OR HIPEC (Hyperthermic intraperitoneal chemotherapy) OR ePIPAC (electrostatic pressurised intra peritoneal aerosol chemotherapy)
3. Patients >18 years of age
4. Patients who are able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8-12 per group (max 24)

Participant exclusion criteria

Unable to give informed consent

Recruitment start date

01/10/2017

Recruitment end date

01/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cwm Taf University Health Board
Royal Glamorgan Hospital
Llantrisant
CF72 8XR
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Organisation

Cwm Taf University Health Board

Sponsor details

Royal Glamorgan Hospital
Llantrisant
CF72 8XR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Tenovus

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned submission of the protocol for publication in the next 3 months. Planned publication of the results in a high impact peer reviewed journal around one year after the end of the trial.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/11/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes