Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
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|ClinicalTrials.gov Identifier: NCT01216813|
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : November 1, 2016
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.
|Condition or disease||Intervention/treatment|
|Adenocarcinoma of the Gastroesophageal Junction Cervical Cancer Endometrial Cancer Esophageal Cancer Fallopian Tube Cancer Gastric Cancer Ovarian Cancer Sarcoma Vaginal Cancer Vulvar Cancer||Other: informational intervention Procedure: assessment of therapy complications Procedure: psychosocial assessment and care|
- 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.
- 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 Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2010|
- 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
- Theories and a hypothesis from data collected for use in a future interventional study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216813
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Principal Investigator:||Clare Shaw, Phd||Royal Marsden NHS Foundation Trust|