Patient perspectives on peritoneal metastasis treatments
| ISRCTN | ISRCTN12469865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12469865 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 06/11/2017
- Registration date
- 05/01/2018
- Last edited
- 15/11/2018
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom
Study information
| Study design | Qualitative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Patient Perspectives on Peritoneal Metastasis Treatments |
| Study acronym | PerMeT |
| Study objectives | 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(s) | Wales REC, 14/09/2017, ref: 17/WA/0247 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2017 |
| Completion date | 01/11/2018 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8-12 per group (max 24) |
| Key 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 |
| Key exclusion criteria | Unable to give informed consent |
| Date of first enrolment | 01/10/2017 |
| Date of final enrolment | 01/10/2018 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Llantrisant
CF72 8XR
United Kingdom
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Glamorgan Hospital
Llantrisant
CF72 8XR
Wales
United Kingdom
"ROR" |
https://ror.org/00rh52j13 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Tenovus Cancer Care
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2019 |
|---|---|
| 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 | Publication and dissemination plan as of 15/11/2018: A final report will be published through Tenovus, the charity that funded the study. Previous 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/11/2018: The trial was stopped due to poor recruitment in one arm and lack of availability of the other two treatment arms (HIPEC and PIPAC) which have been denied funding in Wales. The publication and dissemination plan was updated.
