- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01216813
Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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England
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London, England, United Kingdom, SW3 6JJ
- Royal Marsden - London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment
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Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase
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Patients' met and un-met needs
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Patients' opinion of how to manage any of the issues that arise
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Secondary Outcome Measures
Outcome Measure |
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Theories and a hypothesis from data collected for use in a future interventional study
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Collaborators and Investigators
Investigators
- Principal Investigator: Clare Shaw, Phd, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Adnexal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Fallopian Tube Diseases
- Vaginal Diseases
- Vulvar Diseases
- Sarcoma
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Adenocarcinoma
- Fallopian Tube Neoplasms
- Endometrial Neoplasms
- Vulvar Neoplasms
- Esophageal Neoplasms
- Vaginal Neoplasms
Other Study ID Numbers
- CDR0000686456
- RMNHS-REHABILITATION
- EU-21074
- RMNHS-CCR3434
- MREC-10/H0806/56
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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