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NCT Number: NCT01216813

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

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Key information

Conditions

Adenocarcinoma of the Gastroesophageal Junction Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Cervical Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Sarcoma Stomach Diseases Stomach Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

assessment of therapy complications

Procedure

psychosocial assessment and care

Procedure

Primary outcomes

  1. Patients' perspective of their physical and psychosocial rehabilitation needs following their diagnosis and treatment

  2. Patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase

  3. Patients' met and un-met needs

  4. Patients' opinion of how to manage any of the issues that arise

Secondary outcomes

  1. Theories and a hypothesis from data collected for use in a future interventional study

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2010
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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