Musculoskeletal Health in Adult Haematological Cancer Survivors

Lymphoma Clinical Trial

— SKETCh  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865678
• Other study ID #: CFTsp167
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: The Christie NHS Foundation Trust
• Contact: Salina Tsui, MSc
• Phone: +44 7726781196
• Email: salina.tsui[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Questionnaire study

Inclusion Criteria:

1. Age 18 or above at diagnosis of haematological cancer

2. Diagnosis of haematological cancers: lymphoma or leukaemia

3. Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database

4. Able to give written informed consent

5. Able to read and understand English

Exclusion Criteria:

1.Currently receiving any active cancer treatment

Interview study

Inclusion Criteria:

1. Age 18 or above at diagnosis of haematological cancer

2. Diagnosis of haematological cancers: lymphoma or leukaemia

3. Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database

4. Able to give written or verbal informed consent

5. Able to read and understand English

Exclusion Criteria:

1 .Currently receiving any active cancer treatment

Related Conditions & MeSH terms

• Cancer Survivors
• Leukemia
• Lymphoma
• Musculoskeletal Complication

Intervention

Other:
• Not an intervention study
This is a study administering questionnaire and interviews using mixed quantitative and qualitative methodology with the aim to describe and evaluate musculoskeletal health of adult haematological cancer survivors and its impact to survivors.

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors	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	overall length of the study - 6 months
Primary	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	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.	overall length of the study - 6 months
Primary	Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors	Validated questionniares will be used to assess if patients have sarcopenia (SARC-F questionnaire) and frailty (FiND questionnaire).	overall length of the study - 6 months
Primary	Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors	This will be assessed using validated questionnaires - Short Form Survey (SF36) and Short Musculoskeletal Function Assessment (SMFA).	overall length of the study - 6 months
Primary	Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.	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.	overall length of the study - 6 months
Secondary	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	This will be assessed using regression analysis to determine risk factors that may be associated with poor musculoskeletal health	overall length of the study - 6 months