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

Study Overview
=================
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.

Detailed Description
-----------------
There is recent evidence that routine cancer follow-up is ineffective (Kew, 2011). Knowledge of how best to deliver follow-up remains inadequate and randomised studies are lacking. This trial compares individualised follow-up led by a cancer trained nurse to conventional medical follow-up. Aim: The investigators shall conduct the trial using experienced clinical nurse specialists (CNSs) to deliver self-management focused individual follow-up and evaluate whether this brings about greater improvement in quality of life, is acceptable and cost saving when compared to the standard (conventional) model. Design: Two arm randomised controlled trial. Setting: Specialist gynaecological cancer outpatient services at three cancer centres, one inner city and two urban. Sample size: A sample size of 100 patients, randomised equally to the 2 treatment groups, has been determined for this study. See statistical analysis section. Recruitment: Based on previous experience of recruiting in this population approximately 50% of women approached will agree to take part. The investigators need 1 year to recruit the sample. Randomisation: Participants will be subdivided into two groups those recruited at the inner city centre and those recruited at the suburban. Randomisation will be performed independently for both groups with participants randomly allocated to either the conventional or individualised follow-up in a 1:1 ratio. Allocation of the first participant from a pair to one of the 2 follow-up strategies will be made using randomness derived from atmospheric noise (http://www.random.org); the second participant from each pair will then be allocated to the other group. The intervention: Trial follow-up is 2 years from baseline. Conventional follow-up/treatment as usual This will remain unchanged and involve: one post treatment appointment then appointments every 3 months with a doctor. Routinely a medical history is taken and investigations to monitor disease progression including serum cancer antigen 125 (CA125) tumour marker. A physical examination may be performed. The appointment will sometimes involve CNS input and patients may contact the non-study CNS on an ad hoc basis. Individualised follow-up Patients will meet the study CNS in clinic when they attend for their 4-6 week post treatment appointment. The nurse will negotiate with the patient to agree follow-up arrangements best suited to their needs. E.g. patient-initiated telephone or face-to-face appointments. The nurse will assess the patient at appointments using an assessment proforma. Data collection: Quantitative data Baseline qol questionnaires will be provided by the Research Assistant at the time of written consent and completed and returned prior to disclosure of randomisation. Subsequent questionnaires will be posted to participants with a reply paid envelope. Data will be entered on a 'Patient events' data base and then extracted for all patients for different types of service use during the two-year follow-up period. The investigators will also record primary care contacts and the reasons for these with a questionnaire to General Practitioners. Qualitative interview data Selected patients will take part in a 45-60 minute one-to-one interview at a location convenient to them. The interview will be audio-recorded following consent and anonymised to maintain confidentiality. A semi-structured interview guide will be used to ensure all important topic areas are covered. CNSs will be interviewed in a quiet room away from their clinical area as above. Data Analysis: Quantitative data Differences in mean patient qol and satisfaction and between the two groups will be assessed by 2 sample t-tests. Assuming a two-sided significance level of 5% with 40 in each sample, to achieve 80% power any differences will have to be quite large to be detectable. For the satisfaction scale (0-100), where the estimated common standard deviation = 14.7 (de Bock et al (2004)), a difference between the two groups of 9.3 would be detectable with 80% power. For the anxiety (0-13) and depression (0-14) measures common standard deviation = 2.75 in both cases (de Bock et al 2004), such a difference would need to be 1.74 in both cases. The investigators may be able to detect smaller differences with the planned sample size when taking into account adjustment for baseline values in the sample size calculation comparing the randomised groups (analysis of covariance). For the qol scales there are various sub-scales (0-100) and the evidence from literature sources suggest that for most scales the standard deviation is approximately 20-25 (Greimel et al 2003). Using such a value then, a difference in means, detectable with 80% power, would be between 12.7 and 15.9. Even if the ensuing results are not able to detect clinically important differences between the two groups, the scale scores will provide useful information and may justify further inquiry. The total cost of follow-up for each patient will be calculated by multiplying service use by unit costs obtained from relevant National Health Service (NHS) Reference Costs and summing across all types of use. Unadjusted service use and total costs will be compared between each group using Mann-Whitney two-sample statistics. Qualitative data Interviews will be fully transcribed and analysed according to principles of grounded theory (Strauss and Corbin, 1991).

Official Title
-----------------
A Randomised Study Comparing Satisfaction With Individualised Follow-up Led by a Trained Cancer Nurse Versus Conventional Medical Follow-up After Primary Treatment for Ovarian Cancer.

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Behavioral: Individualised follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 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. Exclusion Criteria A second cancer diagnosis Clinician estimated survival of ≤ 3 months Women receiving treatment for a mental health condition Women who have a learning disability.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional follow-up<br>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. | |
| Experimental: Individualised follow-up<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS): | Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms will be assessed with this 14-item self-rated scale designed for use in the medically ill. | Assessment of change over time from baseline and at 3, 6, 12, 18, & 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynaecological cancer, Nurse-led care, Aftercare, Patient self-management, Quality of life, Relapse free interval, Watch and wait