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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01216813

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Phase
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

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 Design

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 :

Aug 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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