Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
Primary Purpose
Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer
Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
informational intervention
assessment of therapy complications
psychosocial assessment and care
Sponsored by
About this trial
This is an observational trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Royal Marsden - London
Outcomes
Primary Outcome Measures
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 Outcome Measures
Theories and a hypothesis from data collected for use in a future interventional study
Full Information
NCT ID
NCT01216813
First Posted
October 6, 2010
Last Updated
October 31, 2016
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01216813
Brief Title
Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
Official Title
The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer
Study Type
Observational
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer
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
7. Study Design
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Primary Outcome Measure Information:
Title
Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment
Title
Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase
Title
Patients' met and un-met needs
Title
Patients' opinion of how to manage any of the issues that arise
Secondary Outcome Measure Information:
Title
Theories and a hypothesis from data collected for use in a future interventional study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Shaw, Phd
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
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