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

October 31, 2016 updated by: Royal Marsden NHS Foundation Trust

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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- England
  - London, England, United Kingdom, SW3 6JJ
    - Royal Marsden - London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Theories and a hypothesis from data collected for use in a future interventional study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

Principal Investigator: Clare Shaw, Phd, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.