Individualised Versus Conventional Medical Follow-up for Women After Primary Treatment for Ovarian Cancer.

NCT02298855 | Completed

• 1 other identifier: OC_F-UP_V3 28/07/2006
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study in women who have completed primary treatment for ovarian cancer is to investigate the effects of individualised follow-up care delivered by a nurse compared to conventional medical follow-up on quality of life and mood. The investigators aim to determine if the individualised treatment is acceptable to women compared to the conventional treatment.

Conditions

Ovarian Cancer

Keywords

Gynaecological cancer; Nurse-led care; Aftercare; Patient self-management; Quality of life; Relapse free interval; Watch and wait

Outcome Measures

Primary Outcomes (1)

• The European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire QLQ-C30 with ovarian cancer specific module Ov-28.

  is a 30-item questionnaire assessing five 5 functional domains (physical, role, cognitive, emotional and social), 3 symptom domains (nausea/vomiting, fatigue and pain), and a number of specific symptoms (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea) as well as the perceived financial impact of the disease and treatment.The site specific instrument (Ov-28) used with the QLQ-C30 consists of 28 items which are factor analysed into six factors: abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side effects specific to ovarian cancer treatments, hormonal symptoms, body image and sexuality, and attitude to disease/treatment. Higher scores for functioning subscales indicate better functioning. Higher scores in symptom subscales indicate worse symptoms.

  Assessment of change over time from baseline and at 3, 6, 12,18, & 24 months.

Secondary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS):

  Assessment of change over time from baseline and at 3, 6, 12, 18, & 24 months.

Other Outcomes (3)

• Ware Patient Satisfaction Questionnaire (PSQ-III) to measure patients' perceptions of care.

  Asssessment of change over time from baseline and at 3, 6, 12, 18, and 24 months.

• Qualitative interviews with 20-24 selected patients receiving conventional or individualised follow-up care.

  Between 1 & 2 years on follow-up.

• Qualitative interviews with 4 clinical nurse specialists delivering the intervention

  After 1 & 2 years and during delivery follow-up care to study participants.

Study Arms (2)

Conventional follow-up

NO INTERVENTION

Treatment as usual will involve: one post treatment appointment then 3 monthly appointments with a Dr. At appointments: medical history; investigations to monitor disease progression including CA125 tumour marker blood test if this were raised at diagnosis. A physical examination may be performed.

Individualised follow-up

EXPERIMENTAL

Follow-up is delivered by a nurse and frequency and type (telephone or face-to-face) is negotiated to suit their individual situation. Assessment by holistic guide. The intervention is informed by a model of health promoting interactions oriented towards improving self-efficacy. The nurses will provide information and support to help patients manage symptoms and psychological discomfort.

Behavioral: Individualised follow-up

Interventions

Individualised follow-up BEHAVIORAL

Patients allocated to gynaecological cancer nurse specialist at the end of primary treatment. Follow-up is negotiated to suit their individual situation. Type of contact is flexible, primarily by telephone although some women may opt for face-to-face appointments. Patients will be assessed using a holistic guide to identify signs of disease progression, symptoms warranting intervention, and psychological issues. The nurses delivering the intervention are expert in the management of ovarian cancer and will work to a model of health promoting interactions oriented towards improving self-efficacy. The nurses will provide information and support to assist patients to manage troublesome symptoms and live with psychological discomfort.

Individualised follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ovarian cancer (includes fallopian tube and peritoneal cancers)
• Within one month of completion of primary treatment including surgery \& chemotherapy/radiotherapy or surgery alone, irrespective of outcome with regard to remission
• Expected survival ≥3 months
• Agreement to be randomised
• Agreement to give written consent to participate in the study
• Sufficient grasp of English to engage in the self-management focused approach.

You may not qualify if:

• A second cancer diagnosis
• Clinician estimated survival of ≤ 3 months
• Women receiving treatment for a mental health condition
• Women who have a learning disability.

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator

Study Sites (3)

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, Essex., SS0 0RY, United Kingdom

Location

Basildon & Thurrock University Hospitals NHS Foundation Trust

Basildon, Essex, SS16 5NL, United Kingdom

Location

University College London Hospital NHS Foundation Trust

London, London, NW1 2BU, United Kingdom

Location

Related Publications (3)

• Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, Holzner B, Kuljanic K, Lebrec J, D'haese S; EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer. 2003 Jul;39(10):1402-8. doi: 10.1016/s0959-8049(03)00307-1.

  PMID: 12826043 BACKGROUND

• Kew F, Galaal K, Bryant A, Naik R. Evaluation of follow-up strategies for patients with epithelial ovarian cancer following completion of primary treatment. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD006119. doi: 10.1002/14651858.CD006119.pub2.

  PMID: 21678351 BACKGROUND

• de Bock GH, Bonnema J, van der Hage J, Kievit J, van de Velde CJ. Effectiveness of routine visits and routine tests in detecting isolated locoregional recurrences after treatment for early-stage invasive breast cancer: a meta-analysis and systematic review. J Clin Oncol. 2004 Oct 1;22(19):4010-8. doi: 10.1200/JCO.2004.06.080.

  PMID: 15459225 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Anne Lanceley, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 24, 2014

Record last verified: 2014-09

Locations

GB (3)