NCT01216813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2010

Enrollment Period

2 months

First QC Date

October 6, 2010

Last Update Submit

October 31, 2016

Conditions

Adenocarcinoma of the Gastroesophageal JunctionCervical CancerEndometrial CancerEsophageal CancerFallopian Tube CancerGastric CancerOvarian CancerSarcomaVaginal CancerVulvar Cancer

Keywords

esophageal cancergastric cancercervical cancerfallopian tube cancerovarian epithelial cancerovarian germ cell tumorovarian sarcomaovarian stromal cancerendometrial canceruterine sarcomavaginal cancervulvar canceradenocarcinoma of the gastroesophageal junction

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

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

Interventions

informational interventionOTHER
assessment of therapy complicationsPROCEDURE
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsEsophageal NeoplasmsFallopian Tube NeoplasmsStomach NeoplasmsOvarian NeoplasmsSarcomaVaginal NeoplasmsVulvar NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesFallopian Tube DiseasesAdnexal DiseasesStomach DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeVaginal DiseasesVulvar DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Clare Shaw, Phd

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

November 1, 2016

Record last verified: 2010-10

Locations

GB(1)