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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01216813
Other study ID # CDR0000686456
Secondary ID RMNHS-REHABILITA
Status Completed
Phase N/A
First received October 6, 2010
Last updated October 31, 2016
Start date August 2010
Est. completion date December 2010

Study information

Verified date October 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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 Design

N/A


Intervention

Other:
informational intervention

Procedure:
assessment of therapy complications

psychosocial assessment and care


Locations

Country Name City State
United Kingdom Royal Marsden - London London England

Sponsors (1)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment No
Primary Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase No
Primary Patients' met and un-met needs No
Primary Patients' opinion of how to manage any of the issues that arise No
Secondary Theories and a hypothesis from data collected for use in a future interventional study No
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