Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Official Title: | The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer |
- Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment [ Designated as safety issue: No ]
- Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase [ Designated as safety issue: No ]
- Patients' met and un-met needs [ Designated as safety issue: No ]
- Patients' opinion of how to manage any of the issues that arise [ Designated as safety issue: No ]
- Theories and a hypothesis from data collected for use in a future interventional study [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Marsden - London | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Contact Person 44-20-7808-2819 clare.shaw@rmh.nhs.uk | |
| Principal Investigator: | Clare Shaw, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01216813 History of Changes |
| Other Study ID Numbers: | CDR0000686456, RMNHS-REHABILITATION, EU-21074, RMNHS-CCR3434, MREC-10/H0806/56 |
| Study First Received: | October 6, 2010 |
| Last Updated: | October 6, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Vaginal Diseases Adenocarcinoma Adenocarcinoma, Mucinous Endometrial Neoplasms Uterine Cervical Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Ovarian Neoplasms Vaginal Neoplasms Vulvar Neoplasms Fallopian Tube Neoplasms Adenoma Gastrointestinal Neoplasms Sarcoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Gastrointestinal Diseases Digestive System Diseases Digestive System Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013