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Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 6, 2010
Last updated: October 31, 2016
Last verified: October 2010

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
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

Enrollment: 33
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01216813

United Kingdom
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: Clare Shaw, Phd Royal Marsden NHS Foundation Trust
  More Information Identifier: NCT01216813     History of Changes
Other Study ID Numbers: CDR0000686456
Study First Received: October 6, 2010
Last Updated: October 31, 2016

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:
Stomach Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Head and Neck Neoplasms
Esophageal Diseases
Fallopian Tube Diseases
Adnexal Diseases processed this record on May 22, 2017