跳至主要内容
临床试验/NCT05865678
NCT05865678招募中不适用

Musculoskeletal Health in Adult Haematoloigcal Cancer Survivors - a Mixed Methods Study

The Christie NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
650
试验地点
1
主要终点
Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.

研究概览

简要总结

Haematological cancer treatment often includes use of high dose glucocorticoids (steroids), chemotherapy and radiotherapy and current evidence suggests that these patients may have lower bone mineral density after treatment when compared to the general population which can predispose them to increased risk of fragility fractures. Evidence of the impact of these musculoskeletal burden to patients (e.g. quality of life) are not available.

This study aims to describe musculoskeletal complications experienced by long-term haematological cancer survivors and examine the impact of the burden from the patient perspective. The study will be conducted in 2 parts; a questionnaire study and an interview study to help understand the extent of musculoskeletal problems experienced by this group of patients and the impact of this on quality of life.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or above at diagnosis of haematological cancer
  • Diagnosis of haematological cancers: lymphoma or leukaemia
  • Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database
  • Able to give written informed consent
  • Able to read and understand English

排除标准

  • 1.Currently receiving any active cancer treatment
  • Interview study
  • Inclusion Criteria:
  • Age 18 or above at diagnosis of haematological cancer
  • Diagnosis of haematological cancers: lymphoma or leukaemia
  • Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database
  • Able to give written or verbal informed consent
  • Able to read and understand English
  • Exclusion Criteria:
  • 1 .Currently receiving any active cancer treatment

结局指标

主要结局

Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.

时间窗: overall length of the study - 6 months

Semi-structured qualitative interviews will be conducted with a topic guide to ensure same broad topics are explored in the interviews on musculoskeletal health experience, care and information provision.

Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors

时间窗: overall length of the study - 6 months

Validated questionniares will be used to assess if patients have sarcopenia (SARC-F questionnaire) and frailty (FiND questionnaire).

Questionniare study: To calculate the 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors

时间窗: overall length of the study - 6 months

The 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors will be calculated using the Fracture Risk Assessment Tool (FRAX) and Q-Fracture calculator.

Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors

时间窗: overall length of the study - 6 months

Musculoskeletal conditions and related symptoms will be recorded by patients on the study specific questionnaire and the validated questionnaire Nordic musculoskeletal questionnaire (NMQ-E) and gait, arms, legs and spine (GALS) assessment

Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors

时间窗: overall length of the study - 6 months

This will be assessed using validated questionnaires - Short Form Survey (SF36) and Short Musculoskeletal Function Assessment (SMFA).

次要结局

  • Questionnaire study: To describe the likely risk factors that may be associated with musculoskeletal consequences of adult lymphoma and leukaemia survivors Impact of musculoskeletal health(overall length of the study - 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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