Quality of LifeNCT01657175
Quality of Life After Oesophageal or Gastric Cancer Surgery
A study testing Supportive care in people with Quality of Life and Oesophageal Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients quality of life (QOL) after surgery. The project contains 3 part-studies focusing on the patients life after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Oesophageal Cancer, Gastric Cancer
- What is being tested?
- Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Sep 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any stage tumours in the distal third of the oesophagus including type II tumours at the gastro-oesophageal junction
- Transthoracic oesophageal resection with gastric tube reconstructions and circular stapled anastomoses in the upper right chest Postoperative clinical courses without complications, and postoperative anastomotic radiograms without anastomotic leakage
- Macro and microscopically tumour free upper resection margins Willingness, physical and mental capability to comply with the result of the randomization, and ability to follow the study protocol
- Adult >18 years
- Living in the southern of Sweden (Skåne county)
Who cannot join
- Preoperative or planned postoperative chemotherapy or radiotherapy to the tumour area known at the time of discharge from the hospital.
- Postoperative need for continuous treatment with proton pump inhibitors (PPIs) or histamine-2 blockers. Treatment with steroidal or non steroidal anti inflammatory drugs other than occasionally
- Known allergy or side effects to PPIs preventing continuous treatment for one year
- Present drug or alcohol abuse
- Failure to attend at least one postoperative visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.
This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients quality of life (QOL) after surgery. The project contains 3 part-studies focusing on the patients life after surgery.
Data will be collected through focus group interviews and a randomized controlled trial (RCT) study.
Read the detailed description
Introduction:
Patients who have undergone oesophageal resections for cancer have shown reduced quality of life (QOL) during substantial time after surgery. Postoperatively, patients are faced with extensive changes in their daily life including reduced physical and sometimes psychological capacities, problems that may be underestimated by the health care providers.
Worldwide oesophageal cancer is the 8th and gastric cancer the 4th most common cancer diagnoses (National Board of Health and Welfare, 2009). In 2009 in Sweden there were 443 new cases of oesophageal cancer and 882 of gastric cancer (total number of inhabitants in 2009, 9.4 million). Surgery, alone or in combination with chemotherapy or radiotherapy, is the only established treatment and thus offers the only possibility of a cure. After oesophagectomy or gastrectomy the planned hospital stay is approximately two to three weeks, and the expected recovery period is at least one year. The prolonged recovery period is pointed out as an energy-requiring process including physiological, psychological, social and habitual recovery, which increases the challenges for this group of patients after surgery. Even though survival after surgery, for both oesophageal and gastric cancer, has gradually improved, the 5-year survival rate remains at only 28% respectively 27%.
Aim:
The aim of this project is to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients QOL after surgery.
The project contains 3 part-studies that focus on the patients life after surgery.
Method:
In both studies patients that when through oesophagectomy or gastrectomy due to cancer is included. Patients that has suffered a relapse of their cancer disease, are unable to communicate in Swedish or has went through a acute surgery is not included.
Study I and II:
This studies is carried out in accordance with a descriptive explorative design focusing on I: The patients subjective experience of their QOL and II: The patients´ experience and need of supportive care, after surgery for oesophageal/gastric cancer. Data collection is carried out using semi-structured focus group interviews. A total of 17 participants divided into 4 focus groups are included (2-5 years after elective surgery) in the study. Data are to be analysed with qualitative content analysis focusing on the patients experiences of their supportive care needs after surgery.
Study III:
This study is a randomized controlled trial that focus on testing a information and support programme to patients after oesophagectomy or gastrectomy due to cancer. The intervention group gets support from a specialized nurse after surgery which contacts the patients according to a given interval during the follow up period (6 months). The control group follows the regular follow up programme that are used at the hospital where the study is conducted.
The information and support programme are evaluated through validated questionnaires that focus on quality of life (EORTC QLQ-C30 and OES-18), satisfaction whit care (EORTC INPATSAT32), sense of coherence (KASAM) and information needs (EORTC INFO 25). The patients also writes a diary regarding health care contacts after surgery.
A total number of 80 are patients are planed to be included in the study.
- Conditions
- Quality of Life, Oesophageal Cancer, Gastric Cancer
- Being tested
- Supportive care
- Keywords
- Cancer, long-term follow-up, quality of life, Surgery, Nursing
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive careOther
The patients will be randomized to control or supportive care groups.
The control group will be given "care as usual" wich include clinical follow-ups at the surgical department.
The supportive care group get in addition to the clinical follow-ups a supportive care programme including:
- Discharge information about surgery and life after surgery together with their relatives.
- Active telephone contacts 1/week th first month the 2/month up to six month after discharge by a specialized nurs.
- Open telephone line were the patients can call the nursed ruing daytime. Discharge: approximately 2-4 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Supportive care | Experimental | The patients randomized to the supportive care arm get an extended supportive care during the first year after surgery. Receives: Other: Supportive care |
| Control | No intervention | The patients randomized to the control group get "care as usual" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Quality of life will be measured at discharge, 2 weeks, 2, 4 and 6 months after discharge (discharge= approximately 2-4 weeks after surgery).
Quality of life is evaluated using EORTC quality of life instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.
Measured: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge
Secondary outcomes (4)
Satisfaction with care
Satisfaction with care is evaluated using EORTC satisfaction with care instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.
Discharge: approximately 2-4 weeks after surgery
Measured: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
Informational need
Informational needs is evaluated using EORTC INFO 25 instrument, at discharge and 2 weeks, 2,4 and 6 months after discharge.
Discharge: approximately 2-4 weeks after surgery
Measured: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
sense of coherence (KASAM)
KASAM is evaluated using the KASAM instrument, at discharge and 2 weeks, 2,4 and 6 months after discharge.
Discharge: approximately 2-4 weeks after surgery
Measured: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
Contacts with the health care system
Contacts with the health care system is evaluated through a diary at the time for the discharge and 2 weeks, 2,4 and 6 months after discharge.
Discharge: approximately 2-4 weeks after surgery
Measured: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Johansson, MD PHD, Study director, Department of surgery, Skåne university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657175
- Sponsor's protocol ID
- 2009 /117
- Status last verified
- Apr 2017
- First submitted
- 29 Jun 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.
- ClinicalTrials.gov ID
- NCT01657175
- Acronym / sponsor ID
- 2009 /117
- Conditions
- Quality of Life, Oesophageal Cancer, Gastric Cancer
- Keywords
- Cancer, long-term follow-up, quality of life, Surgery, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Aug 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.
This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients quality of life (QOL) after surgery. The project contains 3 part-studies focusing on the patients life after surgery.
Data will be collected through focus group interviews and a randomized controlled trial (RCT) study.
Detailed description
Introduction:
Patients who have undergone oesophageal resections for cancer have shown reduced quality of life (QOL) during substantial time after surgery. Postoperatively, patients are faced with extensive changes in their daily life including reduced physical and sometimes psychological capacities, problems that may be underestimated by the health care providers.
Worldwide oesophageal cancer is the 8th and gastric cancer the 4th most common cancer diagnoses (National Board of Health and Welfare, 2009). In 2009 in Sweden there were 443 new cases of oesophageal cancer and 882 of gastric cancer (total number of inhabitants in 2009, 9.4 million). Surgery, alone or in combination with chemotherapy or radiotherapy, is the only established treatment and thus offers the only possibility of a cure. After oesophagectomy or gastrectomy the planned hospital stay is approximately two to three weeks, and the expected recovery period is at least one year. The prolonged recovery period is pointed out as an energy-requiring process including physiological, psychological, social and habitual recovery, which increases the challenges for this group of patients after surgery. Even though survival after surgery, for both oesophageal and gastric cancer, has gradually improved, the 5-year survival rate remains at only 28% respectively 27%.
Aim:
The aim of this project is to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients QOL after surgery.
The project contains 3 part-studies that focus on the patients life after surgery.
Method:
In both studies patients that when through oesophagectomy or gastrectomy due to cancer is included. Patients that has suffered a relapse of their cancer disease, are unable to communicate in Swedish or has went through a acute surgery is not included.
Study I and II:
This studies is carried out in accordance with a descriptive explorative design focusing on I: The patients subjective experience of their QOL and II: The patients´ experience and need of supportive care, after surgery for oesophageal/gastric cancer. Data collection is carried out using semi-structured focus group interviews. A total of 17 participants divided into 4 focus groups are included (2-5 years after elective surgery) in the study. Data are to be analysed with qualitative content analysis focusing on the patients experiences of their supportive care needs after surgery.
Study III:
This study is a randomized controlled trial that focus on testing a information and support programme to patients after oesophagectomy or gastrectomy due to cancer. The intervention group gets support from a specialized nurse after surgery which contacts the patients according to a given interval during the follow up period (6 months). The control group follows the regular follow up programme that are used at the hospital where the study is conducted.
The information and support programme are evaluated through validated questionnaires that focus on quality of life (EORTC QLQ-C30 and OES-18), satisfaction whit care (EORTC INPATSAT32), sense of coherence (KASAM) and information needs (EORTC INFO 25). The patients also writes a diary regarding health care contacts after surgery.
A total number of 80 are patients are planed to be included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive care | Experimental | Other: Supportive careThe patients randomized to the supportive care arm get an extended supportive care during the first year after surgery. |
| Control | No intervention | –The patients randomized to the control group get "care as usual" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with any stage tumours in the distal third of the oesophagus including type II tumours at the gastro-oesophageal junction
- Transthoracic oesophageal resection with gastric tube reconstructions and circular stapled anastomoses in the upper right chest Postoperative clinical courses without complications, and postoperative anastomotic radiograms without anastomotic leakage
- Macro and microscopically tumour free upper resection margins Willingness, physical and mental capability to comply with the result of the randomization, and ability to follow the study protocol
- Adult >18 years
- Living in the southern of Sweden (Skåne county)
Key exclusion criteria (5 listed)
- Preoperative or planned postoperative chemotherapy or radiotherapy to the tumour area known at the time of discharge from the hospital.
- Postoperative need for continuous treatment with proton pump inhibitors (PPIs) or histamine-2 blockers. Treatment with steroidal or non steroidal anti inflammatory drugs other than occasionally
- Known allergy or side effects to PPIs preventing continuous treatment for one year
- Present drug or alcohol abuse
- Failure to attend at least one postoperative visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive careThe patients will be randomized to control or supportive care groups. The control group will be given "care as usual" wich include clinical follow-ups at the surgical department. The supportive care group get in addition to the clinical follow-ups a supportive care programme including: * Discharge information about surgery and life after surgery together with their relatives. * Active telephone contacts 1/week th first month the 2/month up to six month after discharge by a specialized nurs. * Open telephone line were the patients can call the nursed ruing daytime. Discharge: approximately 2-4 weeks after surgery | Other | Supportive care |
Primary outcome
Quality of Life
Time frame: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge
Quality of life will be measured at discharge, 2 weeks, 2, 4 and 6 months after discharge (discharge= approximately 2-4 weeks after surgery). Quality of life is evaluated using EORTC quality of life instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.
4 secondary outcomes
Satisfaction with care
Time frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
Informational need
Time frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
sense of coherence (KASAM)
Time frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
Contacts with the health care system
Time frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.
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 12 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Jan Johansson, MD PHD study director
Department of surgery, Skåne university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care in people with Quality of Life and Oesophageal Cancer, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 5 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 12 Apr 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 Sweden. 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?
Quality of Life (time frame: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge). 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 12 Apr 2017.