Clinical trial NCT01216813: Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
Official title: The Rehabilitation Needs of People Who Have Had an Upper Gastrointestinal or a Gynecological Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Cervical Cancer
Endometrial Cancer
Esophageal Cancer
Fallopian Tube Cancer
Gastric Cancer
Ovarian Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-10-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 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

Primary outcomes:
measure: Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment
measure: Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase
measure: Patients' met and un-met needs
measure: Patients' opinion of how to manage any of the issues that arise
Secondary outcomes:
measure: Theories and a hypothesis from data collected for use in a future interventional study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden - London
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Clare Shaw, Phd
role: PRINCIPAL_INVESTIGATOR
References: