Clinical trial NCT05865678: Musculoskeletal Health in Adult Haematological Cancer Survivors
Official title: Musculoskeletal Health in Adult Haematoloigcal Cancer Survivors - a Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Leukemia
Cancer Survivors
Musculoskeletal Complication
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2023-05-19
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be identified from The Christie NHS Foundation Trust local haematology and lymphoma survivors' clinical patient databases. The haematology database used is the HSCT database that records all haematology patients that have undergo haematopoietic stem cell transplant. For lymphoma patients, the ADAPT (Managed Local Follow up of Long-Term Lymphoma Survivors) database will be used which records lymphoma patients that are cured and had 5 years regular hospital follow up post treatment.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors
timeFrame: overall length of the study - 6 months
measure: 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
timeFrame: overall length of the study - 6 months
measure: Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors
timeFrame: overall length of the study - 6 months
measure: Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors
timeFrame: overall length of the study - 6 months
measure: Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.
timeFrame: overall length of the study - 6 months
Secondary outcomes:
measure: 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
timeFrame: overall length of the study - 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: