Adenocarcinoma of the Gastroesophageal JunctionNCT01216813
Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
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
RATIONALE: Gathering information from patients who have undergone treatment for upper gastrointestinal cancer or gynecological cancer may help doctors learn more about patients' physical and psychosocial rehabilitation needs and plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer
- What is being tested?
- informational intervention, assessment of therapy complications and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Dec 2010
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of upper gastrointestinal (GI) or gynecological cancer
- Must have completed initial treatment for upper GI or gynecological cancer
- Received primary treatment within the Royal Marsden NHS Foundation Trust
- Will be on a treatment pathway with radical intent or be post-treatment
- Reported that they have experienced a physical or psychosocial need resulting from the disease or its treatment
PATIENT CHARACTERISTICS:
- Able to attend the specialist center for a focus group session
- Willing and able to articulate their experiences in English
- Not eligible for or receiving palliative or end-of-life care
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer
RATIONALE: Gathering information from patients who have undergone treatment for upper gastrointestinal cancer or gynecological cancer may help doctors learn more about patients' physical and psychosocial rehabilitation needs and plan the best treatment.
PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological cancer.
Read the detailed description
OBJECTIVES:
Primary
- To explore the patients' perspective of their physical and psychosocial rehabilitation needs following the diagnosis and treatment for an upper gastrointestinal or a gynecological cancer.
- To assess patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase.
- To explore patients' met and un-met needs.
- To explore the patients' opinion of how it might be possible to manage any of the issues that arise.
Secondary
- To generate theories and a hypothesis from the data collected for use in a future interventional study.
OUTLINE: The study consist of a series of focus groups that take place in a private room within the Royal Marsden Hospital in the United Kingdom. Patients attend only one focus group session, which is audio-tape recorded. The focus groups discuss and explore the patient's needs and experiences using a semi-structured interview question schedule over 60-90 minutes. The groups are single-sex groups to allow the patients to express themselves freely with respect to any sensitive topics they may wish to discuss. If individual patient issues arise from the group discussions, the lead researcher may refer the patient to a member of the hospital team, the patient's physician, or for appropriate psychological support.
Data from the focus group dialogue and patients' baseline demographic information are analyzed. The results from this study are used to design an interventional study in the Rehabilitation Department.
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Being tested
- informational intervention, assessment of therapy complications, psychosocial assessment and care
- Keywords
- esophageal cancer, gastric cancer, cervical cancer, fallopian tube cancer, ovarian epithelial cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, endometrial cancer, uterine sarcoma, vaginal cancer, vulvar cancer, adenocarcinoma of the gastroesophageal junction
- 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.
informational interventionOther
assessment of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment
Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase
Patients' met and un-met needs
Patients' opinion of how to manage any of the issues that arise
Secondary outcomes (1)
Theories and a hypothesis from data collected for use in a future interventional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionDec 2010
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
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Clare Shaw, Phd, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216813
- Sponsor's protocol ID
- CDR0000686456
- Other IDs
- RMNHS-REHABILITATION, EU-21074, RMNHS-CCR3434, MREC-10/H0806/56
- Status last verified
- Oct 2010
- First submitted
- 6 Oct 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer
- ClinicalTrials.gov ID
- NCT01216813
- Acronym / sponsor ID
- CDR0000686456
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Keywords
- esophageal cancer, gastric cancer, cervical cancer, fallopian tube cancer, ovarian epithelial cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Oct 2010 (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.
RATIONALE: Gathering information from patients who have undergone treatment for upper gastrointestinal cancer or gynecological cancer may help doctors learn more about patients' physical and psychosocial rehabilitation needs and plan the best treatment.
PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological cancer.
Detailed description
OBJECTIVES:
Primary
- To explore the patients' perspective of their physical and psychosocial rehabilitation needs following the diagnosis and treatment for an upper gastrointestinal or a gynecological cancer.
- To assess patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase.
- To explore patients' met and un-met needs.
- To explore the patients' opinion of how it might be possible to manage any of the issues that arise.
Secondary
- To generate theories and a hypothesis from the data collected for use in a future interventional study.
OUTLINE: The study consist of a series of focus groups that take place in a private room within the Royal Marsden Hospital in the United Kingdom. Patients attend only one focus group session, which is audio-tape recorded. The focus groups discuss and explore the patient's needs and experiences using a semi-structured interview question schedule over 60-90 minutes. The groups are single-sex groups to allow the patients to express themselves freely with respect to any sensitive topics they may wish to discuss. If individual patient issues arise from the group discussions, the lead researcher may refer the patient to a member of the hospital team, the patient's physician, or for appropriate psychological support.
Data from the focus group dialogue and patients' baseline demographic information are analyzed. The results from this study are used to design an interventional study in the Rehabilitation Department.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| informational intervention | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment
Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase
Patients' met and un-met needs
Patients' opinion of how to manage any of the issues that arise
1 secondary outcome
Theories and a hypothesis from data collected for use in a future interventional study
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 1 Nov 2016.
Related trials for Adenocarcinoma of the Gastroesophageal Junction
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
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 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?
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 1 Nov 2016. 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?
Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment. The study lists 4 primary outcomes in all. 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 1 Nov 2016.