Adenocarcinoma of the Gastroesophageal JunctionNCT01582906
A Survivorship Care Plan for Gynaecological Cancer Patients
An observational study of Adenocarcinoma of the Gastroesophageal Junction and Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We aim to capture patients with gynaecological cancers at Stage I or II. Overall there were approximately 500 referrals of patients with Stage I or II gynaecological cancer to the Royal Marsden NHS Foundation Trust (RM) in the year April 2009 to April 2010. There were 729 gynaecological referrals of all stages of cancer. Of these, 333 were referred to the surgical team and 396 to the medical teams. Of those 729 patients, 378 were referred to the Rehabilitation Department, the majority of whom were referred post-surgery and seen as inpatients, leaving 48% of patients with gynaecological cancer never seen by a rehabilitation professional at RM.
Who may be able to join
- Participants will: have a diagnosis of and have completed initial treatment for Stage I or II gynaecological cancer;
- will have recently completed a treatment pathway with radical intent;
- have received primary treatment at The Royal Marsden NHS Foundation Trust (RM);
- report that they have experienced a physical or psychosocial need resulting from the disease or it's treatment;
- be aged over 18 years;
- be willing and able to articulate their needs.
Who cannot join
- Those eligible for end-of-life care,
- those with metastatic disease
- those that lack capacity to understand the purpose of the study and participate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Does a Post Treatment Survivorship Care Plan Improve Gynaecological Cancer Patient's Quality of Life and Self Efficacy? A Mixed Methods Pilot Study.
After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research on best models of posttreatment rehabilitation support for women posttreatment for gynaecological cancer is limited. The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life.
Secondary objectives are to determine any additional benefit to general selfefficacy, generic health related quality of life or social and health economics for patients who have completed treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives of the intervention. The study will be open to patients attending the outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed treatment for Stage I or II gynaecological cancer. They will report that they have experienced a physical or psychosocial need resulting from the disease or its treatment; be aged over 18 years and be willing and able to articulate their needs. The study will last for six months for each participant. It will involve completing questionnaires and attending two extra rehabilitation appointments to develop a survivorship care plan at the hospital may also include attending for an interview about being involved in the study for those randomised to the intervention group
Read the detailed description
Purpose and design We conducted a preliminary qualitative study last year (Rec Ref 10/H0608/56) where gynaecological patients reported unmet rehabilitation care needs, both physical and psychosocial. At the end of treatment patients said that they were unaware of how to resolve these needs. They also reported that they wanted support and information to manage consequences of cancer and treatment themselves rather than become 'overmedicalised' and require treatment from a professional, if that were possible (Sandsund et al., 2011). Since there is as yet no body of evidence to prove a best model of delivery we have developed this study to reflect the intervention participants in the study suggested would best support them.
During the preliminary study participants made suggestions that may improve their journey through treatment. Of the five focus groups all suggested a meeting in clinic with a rehabilitation professional at the end of their treatment to explore their rehabilitation needs. The intervention was as such described and defined by the patients in the preliminary study.
After the study was analysed and presented to the Rehabilitation Research Group discussions started regarding research questions and a design for this interventional study. The Head of Therapies, a representative from the Psychological Care/ Psychological Support Service and a Nurse Consultant in Living with and Beyond Cancer have been involved in the development of the protocol from the preliminary study in order to ensure its' conduct will be feasible within The Royal Marsden NHS Foundation Trust (RM).
There have been discussions amongst the research group and the authors as to the best way to clinically screen for physical and psychosocial problems. The FACTG, the EORTC and the Distress Thermometer were most thoroughly considered. The Distress Thermometer was chosen as the questions were felt to best cover issues we felt the participant group may have. It has been used in a National Cancer Survivorship Initiative/ Department of Health project for which RM was one of the sites. on evaluation of the project it was found to be clinically useful as a screening tool and was acceptable to our patients.
The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - C30 (EORTC QLQC30),General Self Efficacy Scale (GSES), Short Form 36 (SF36) were chosen for their wide use in rehabilitation intervention studies because of their ability to detect change over time reliably in cancer populations. We believe that the primary outcome measure the EORTC will be sensitive enough to detect changes due to the intervention. The statistician has given advice to this regard and provided the statistical support for the study to date.
A Health Economist who is involved with other studies at RM has developed the study specific forms to measure the economic evaluation of impact on health and social care provision. She will perform the cost analysis of this information to see if the intervention has had any health or social economic impact. The patient's perspectives of the intervention will be sought using qualitative interviews for a randomised sample of those completing the study. This will be used to assess the acceptability of the intervention to patients.
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Fallopian Tube Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Sarcoma, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Participants randomised to the control group would receive usual rehabilitation care via the existing referral pathways. | |
| Intervention Group | Participants randomised to the intervention group will be offered two rehabilitation appointments at three month intervals. They will complete the screening tool, the Distress (Concerns) Thermometer before the first appointment; this will be reviewed after three months. Appointments will make use of communication skills recognised to promote motivation via self-efficacy. Self efficacy is a person's belief in their ability to achieve a goal. Their sense of mastery will influence their behaviour, their perception of stress and the effort they put into achieving that goal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EORTC
The primary endpoint will be the change from baseline to six months in EORTC global quality of life score. The mean change with 95% confidence interval will be evaluated for each arm. All patients will be included in an ITT analysis: patients with missing data at six months will be assumed to have a change of 0 points from baseline.
Measured: 6 months
Secondary outcomes (1)
Improvement in Global QOL
Time to improvement in global QOL (EORTC Q30) from baseline - this will be done using Kaplan-Meier type time to event analysis, where an event is defined as a change >ten points from baseline, with patients who do not improve or are lost to follow-up censored at last completed EORTC questionnaire. To be presented graphically by arm, with medians and their 95% confidence intervals reported by arm.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
- Investigators
- Clare Shaw, Phd, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582906
- Sponsor's protocol ID
- CCR 3664
- Status last verified
- Nov 2017
- First submitted
- 20 Apr 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Post Treatment Survivorship Care Plan Improve Gynaecological Cancer Patient's Quality of Life and Self Efficacy? A Mixed Methods Pilot Study.
- ClinicalTrials.gov ID
- NCT01582906
- Acronym / sponsor ID
- CCR 3664
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- Aug 2011 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research on best models of posttreatment rehabilitation support for women posttreatment for gynaecological cancer is limited. The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life.
Secondary objectives are to determine any additional benefit to general selfefficacy, generic health related quality of life or social and health economics for patients who have completed treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives of the intervention. The study will be open to patients attending the outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed treatment for Stage I or II gynaecological cancer. They will report that they have experienced a physical or psychosocial need resulting from the disease or its treatment; be aged over 18 years and be willing and able to articulate their needs. The study will last for six months for each participant. It will involve completing questionnaires and attending two extra rehabilitation appointments to develop a survivorship care plan at the hospital may also include attending for an interview about being involved in the study for those randomised to the intervention group
Detailed description
Purpose and design We conducted a preliminary qualitative study last year (Rec Ref 10/H0608/56) where gynaecological patients reported unmet rehabilitation care needs, both physical and psychosocial. At the end of treatment patients said that they were unaware of how to resolve these needs. They also reported that they wanted support and information to manage consequences of cancer and treatment themselves rather than become 'overmedicalised' and require treatment from a professional, if that were possible (Sandsund et al., 2011). Since there is as yet no body of evidence to prove a best model of delivery we have developed this study to reflect the intervention participants in the study suggested would best support them.
During the preliminary study participants made suggestions that may improve their journey through treatment. Of the five focus groups all suggested a meeting in clinic with a rehabilitation professional at the end of their treatment to explore their rehabilitation needs. The intervention was as such described and defined by the patients in the preliminary study.
After the study was analysed and presented to the Rehabilitation Research Group discussions started regarding research questions and a design for this interventional study. The Head of Therapies, a representative from the Psychological Care/ Psychological Support Service and a Nurse Consultant in Living with and Beyond Cancer have been involved in the development of the protocol from the preliminary study in order to ensure its' conduct will be feasible within The Royal Marsden NHS Foundation Trust (RM).
There have been discussions amongst the research group and the authors as to the best way to clinically screen for physical and psychosocial problems. The FACTG, the EORTC and the Distress Thermometer were most thoroughly considered. The Distress Thermometer was chosen as the questions were felt to best cover issues we felt the participant group may have. It has been used in a National Cancer Survivorship Initiative/ Department of Health project for which RM was one of the sites. on evaluation of the project it was found to be clinically useful as a screening tool and was acceptable to our patients.
The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - C30 (EORTC QLQC30),General Self Efficacy Scale (GSES), Short Form 36 (SF36) were chosen for their wide use in rehabilitation intervention studies because of their ability to detect change over time reliably in cancer populations. We believe that the primary outcome measure the EORTC will be sensitive enough to detect changes due to the intervention. The statistician has given advice to this regard and provided the statistical support for the study to date.
A Health Economist who is involved with other studies at RM has developed the study specific forms to measure the economic evaluation of impact on health and social care provision. She will perform the cost analysis of this information to see if the intervention has had any health or social economic impact. The patient's perspectives of the intervention will be sought using qualitative interviews for a randomised sample of those completing the study. This will be used to assess the acceptability of the intervention to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Participants randomised to the control group would receive usual rehabilitation care via the existing referral pathways. |
| Intervention Group | – | –Participants randomised to the intervention group will be offered two rehabilitation appointments at three month intervals. They will complete the screening tool, the Distress (Concerns) Thermometer before the first appointment; this will be reviewed after three months. Appointments will make use of communication skills recognised to promote motivation via self-efficacy. Self efficacy is a person's belief in their ability to achieve a goal. Their sense of mastery will influence their behaviour, their perception of stress and the effort they put into achieving that goal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We aim to capture patients with gynaecological cancers at Stage I or II. Overall there were approximately 500 referrals of patients with Stage I or II gynaecological cancer to the Royal Marsden NHS Foundation Trust (RM) in the year April 2009 to April 2010. There were 729 gynaecological referrals of all stages of cancer. Of these, 333 were referred to the surgical team and 396 to the medical teams. Of those 729 patients, 378 were referred to the Rehabilitation Department, the majority of whom were referred post-surgery and seen as inpatients, leaving 48% of patients with gynaecological cancer never seen by a rehabilitation professional at RM.
Key inclusion criteria (6 listed)
- Participants will: have a diagnosis of and have completed initial treatment for Stage I or II gynaecological cancer;
- will have recently completed a treatment pathway with radical intent;
- have received primary treatment at The Royal Marsden NHS Foundation Trust (RM);
- report that they have experienced a physical or psychosocial need resulting from the disease or it's treatment;
- be aged over 18 years;
Key exclusion criteria (3 listed)
- Those eligible for end-of-life care,
- those with metastatic disease
- those that lack capacity to understand the purpose of the study and participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in EORTC
Time frame: 6 months
The primary endpoint will be the change from baseline to six months in EORTC global quality of life score. The mean change with 95% confidence interval will be evaluated for each arm. All patients will be included in an ITT analysis: patients with missing data at six months will be assumed to have a change of 0 points from baseline.
1 secondary outcome
Improvement in Global QOL
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Shaw, Phd principal investigator
Royal Marsden Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Gastroesophageal Junction and Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EORTC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.