A Survivorship Care Plan for Gynaecological Cancer Patients

NCT01582906 | Completed

• 1 other identifier: CCR 3664
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research on best models of posttreatment rehabilitation support for women posttreatment for gynaecological cancer is limited. The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life. Secondary objectives are to determine any additional benefit to general selfefficacy, generic health related quality of life or social and health economics for patients who have completed treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives of the intervention. The study will be open to patients attending the outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed treatment for Stage I or II gynaecological cancer. They will report that they have experienced a physical or psychosocial need resulting from the disease or its treatment; be aged over 18 years and be willing and able to articulate their needs. The study will last for six months for each participant. It will involve completing questionnaires and attending two extra rehabilitation appointments to develop a survivorship care plan at the hospital may also include attending for an interview about being involved in the study for those randomised to the intervention group

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Fallopian Tube Cancer; Gastric Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

• Change in EORTC

  The primary endpoint will be the change from baseline to six months in EORTC global quality of life score. The mean change with 95% confidence interval will be evaluated for each arm. All patients will be included in an ITT analysis: patients with missing data at six months will be assumed to have a change of 0 points from baseline.

  6 months

Secondary Outcomes (1)

• Improvement in Global QOL

  1 year

Study Arms (2)

Control Group

Participants randomised to the control group would receive usual rehabilitation care via the existing referral pathways.

Intervention Group

Participants randomised to the intervention group will be offered two rehabilitation appointments at three month intervals. They will complete the screening tool, the Distress (Concerns) Thermometer before the first appointment; this will be reviewed after three months. Appointments will make use of communication skills recognised to promote motivation via self-efficacy. Self efficacy is a person's belief in their ability to achieve a goal. Their sense of mastery will influence their behaviour, their perception of stress and the effort they put into achieving that goal.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We aim to capture patients with gynaecological cancers at Stage I or II. Overall there were approximately 500 referrals of patients with Stage I or II gynaecological cancer to the Royal Marsden NHS Foundation Trust (RM) in the year April 2009 to April 2010. There were 729 gynaecological referrals of all stages of cancer. Of these, 333 were referred to the surgical team and 396 to the medical teams. Of those 729 patients, 378 were referred to the Rehabilitation Department, the majority of whom were referred post-surgery and seen as inpatients, leaving 48% of patients with gynaecological cancer never seen by a rehabilitation professional at RM.

You may qualify if:

• Participants will: have a diagnosis of and have completed initial treatment for Stage I or II gynaecological cancer;
• will have recently completed a treatment pathway with radical intent;
• have received primary treatment at The Royal Marsden NHS Foundation Trust (RM);
• report that they have experienced a physical or psychosocial need resulting from the disease or it's treatment;
• be aged over 18 years;
• be willing and able to articulate their needs.

You may not qualify if:

• Those eligible for end-of-life care,
• those with metastatic disease
• those that lack capacity to understand the purpose of the study and participate

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• University of Surrey: collaborator

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Fallopian Tube Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Sarcoma; Vaginal Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Fallopian Tube Diseases; Adnexal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Vaginal Diseases; Vulvar Diseases

Study Officials

• Clare Shaw, Phd

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: August 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

GB (1)