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

Ovarian Cancer Clinical Trial

Official title:

The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Gastroesophageal Junction
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gastric Cancer
• Ovarian Cancer
• Sarcoma
• Stomach Neoplasms
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

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