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A Survivorship Care Plan for Gynaecological Cancer Patients

2017년 11월 21일 업데이트: Royal Marsden NHS Foundation Trust

Does a Post Treatment Survivorship Care Plan Improve Gynaecological Cancer Patient's Quality of Life and Self Efficacy? A Mixed Methods Pilot Study.

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

연구 개요

상세 설명

Purpose and design We conducted a preliminary qualitative study last year (Rec Ref 10/H0608/56) where gynaecological patients reported unmet rehabilitation care needs, both physical and psychosocial. At the end of treatment patients said that they were unaware of how to resolve these needs. They also reported that they wanted support and information to manage consequences of cancer and treatment themselves rather than become 'overmedicalised' and require treatment from a professional, if that were possible (Sandsund et al., 2011). Since there is as yet no body of evidence to prove a best model of delivery we have developed this study to reflect the intervention participants in the study suggested would best support them.

During the preliminary study participants made suggestions that may improve their journey through treatment. Of the five focus groups all suggested a meeting in clinic with a rehabilitation professional at the end of their treatment to explore their rehabilitation needs. The intervention was as such described and defined by the patients in the preliminary study.

After the study was analysed and presented to the Rehabilitation Research Group discussions started regarding research questions and a design for this interventional study. The Head of Therapies, a representative from the Psychological Care/ Psychological Support Service and a Nurse Consultant in Living with and Beyond Cancer have been involved in the development of the protocol from the preliminary study in order to ensure its' conduct will be feasible within The Royal Marsden NHS Foundation Trust (RM).

There have been discussions amongst the research group and the authors as to the best way to clinically screen for physical and psychosocial problems. The FACTG, the EORTC and the Distress Thermometer were most thoroughly considered. The Distress Thermometer was chosen as the questions were felt to best cover issues we felt the participant group may have. It has been used in a National Cancer Survivorship Initiative/ Department of Health project for which RM was one of the sites. on evaluation of the project it was found to be clinically useful as a screening tool and was acceptable to our patients.

The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - C30 (EORTC QLQC30),General Self Efficacy Scale (GSES), Short Form 36 (SF36) were chosen for their wide use in rehabilitation intervention studies because of their ability to detect change over time reliably in cancer populations. We believe that the primary outcome measure the EORTC will be sensitive enough to detect changes due to the intervention. The statistician has given advice to this regard and provided the statistical support for the study to date.

A Health Economist who is involved with other studies at RM has developed the study specific forms to measure the economic evaluation of impact on health and social care provision. She will perform the cost analysis of this information to see if the intervention has had any health or social economic impact. The patient's perspectives of the intervention will be sought using qualitative interviews for a randomised sample of those completing the study. This will be used to assess the acceptability of the intervention to patients.

연구 유형

관찰

등록 (실제)

150

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • London, 영국, SW3 6JJ
        • Royal Marsden Hospital NHS Foundation Trust

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in EORTC
기간: 6 months
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

2차 결과 측정

결과 측정
측정값 설명
기간
Improvement in Global QOL
기간: 1 year
Time to improvement in global QOL (EORTC Q30) from baseline - this will be done using Kaplan-Meier type time to event analysis, where an event is defined as a change >ten points from baseline, with patients who do not improve or are lost to follow-up censored at last completed EORTC questionnaire. To be presented graphically by arm, with medians and their 95% confidence intervals reported by arm.
1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Clare Shaw, Phd, Royal Marsden Hospital NHS Foundation Trust

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 8월 1일

기본 완료 (실제)

2014년 3월 1일

연구 완료 (실제)

2015년 4월 1일

연구 등록 날짜

최초 제출

2012년 4월 20일

QC 기준을 충족하는 최초 제출

2012년 4월 20일

처음 게시됨 (추정)

2012년 4월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 11월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 11월 21일

마지막으로 확인됨

2017년 11월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
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