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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01216813
First received: October 6, 2010
Last updated: August 23, 2013
Last verified: October 2010
  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

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 [ 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 ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01216813

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   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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: August 23, 2013
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:
Endometrial Neoplasms
Adenocarcinoma
Uterine Cervical Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Fallopian Tube Neoplasms
Gastrointestinal Neoplasms
Sarcoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases

ClinicalTrials.gov processed this record on July 22, 2014