NCT05865678

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

April 24, 2023

Last Update Submit

February 20, 2024

Conditions

LymphomaLeukemiaCancer SurvivorsMusculoskeletal Complication

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • 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

Study Arms (32)

5-10 years post cancer treatment; male; age at diagnosis 18-30

Other: Not an intervention study

5-10 years post cancer treatment; male; age at diagnosis 31-50

Other: Not an intervention study

5-10 years post cancer treatment; male; age at diagnosis 51-70

Other: Not an intervention study

5-10 years post cancer treatment; male; age at diagnosis 70+

Other: Not an intervention study

5-10 years post cancer treatment; female; age at diagnosis 18-30

Other: Not an intervention study

5-10 years post cancer treatment; female; age at diagnosis 31-50

Other: Not an intervention study

5-10 years post cancer treatment; female; age at diagnosis 51-70

Other: Not an intervention study

5-10 years post cancer treatment; female; age at diagnosis 70+

Other: Not an intervention study

11-20 years post cancer treatment; male; age at diagnosis 18-30

Other: Not an intervention study

11-20 years post cancer treatment; male; age at diagnosis 31-50

Other: Not an intervention study

11-20 years post cancer treatment; male; age at diagnosis 51-70

Other: Not an intervention study

11-20 years post cancer treatment; male; age at diagnosis 70+

Other: Not an intervention study

11-20 years post cancer treatment; female; age at diagnosis 18-30

Other: Not an intervention study

11-20 years post cancer treatment; female; age at diagnosis 31-50

Other: Not an intervention study

11-20 years post cancer treatment; female; age at diagnosis 51-70

Other: Not an intervention study

11-20 years post cancer treatment; female; age at diagnosis 70+

Other: Not an intervention study

21-30 years post cancer treatment; male; age at diagnosis 18-30

Other: Not an intervention study

21-30 years post cancer treatment; male; age at diagnosis 31-50

Other: Not an intervention study

21-30 years post cancer treatment; male; age at diagnosis 51-70

Other: Not an intervention study

21-30 years post cancer treatment; male; age at diagnosis 70+

Other: Not an intervention study

21-30 years post cancer treatment; female; age at diagnosis 18-30

Other: Not an intervention study

21-30 years post cancer treatment; female; age at diagnosis 31-50

Other: Not an intervention study

21-30 years post cancer treatment; female; age at diagnosis 51-70

Other: Not an intervention study

21-30 years post cancer treatment; female; age at diagnosis 70+

Other: Not an intervention study

30 years + post cancer treatment; male; age at diagnosis 18-30

Other: Not an intervention study

30 years + post cancer treatment; male; age at diagnosis 31-50

Other: Not an intervention study

30 years + post cancer treatment; male; age at diagnosis 51-70

Other: Not an intervention study

30 years + post cancer treatment; male; age at diagnosis 70+

Other: Not an intervention study

30 years + post cancer treatment; female; age at diagnosis 18-30

Other: Not an intervention study

30 years + post cancer treatment; female; age at diagnosis 31-50

Other: Not an intervention study

30 years + post cancer treatment; female; age at diagnosis 51-70

Other: Not an intervention study

30 years + post cancer treatment; female; age at diagnosis 70+

Other: Not an intervention study

Interventions

Not an intervention studyOTHER

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.

11-20 years post cancer treatment; female; age at diagnosis 18-3011-20 years post cancer treatment; female; age at diagnosis 31-5011-20 years post cancer treatment; female; age at diagnosis 51-7011-20 years post cancer treatment; female; age at diagnosis 70+11-20 years post cancer treatment; male; age at diagnosis 18-3011-20 years post cancer treatment; male; age at diagnosis 31-5011-20 years post cancer treatment; male; age at diagnosis 51-7011-20 years post cancer treatment; male; age at diagnosis 70+21-30 years post cancer treatment; female; age at diagnosis 18-3021-30 years post cancer treatment; female; age at diagnosis 31-5021-30 years post cancer treatment; female; age at diagnosis 51-7021-30 years post cancer treatment; female; age at diagnosis 70+21-30 years post cancer treatment; male; age at diagnosis 18-3021-30 years post cancer treatment; male; age at diagnosis 31-5021-30 years post cancer treatment; male; age at diagnosis 51-7021-30 years post cancer treatment; male; age at diagnosis 70+30 years + post cancer treatment; female; age at diagnosis 18-3030 years + post cancer treatment; female; age at diagnosis 31-5030 years + post cancer treatment; female; age at diagnosis 51-7030 years + post cancer treatment; female; age at diagnosis 70+30 years + post cancer treatment; male; age at diagnosis 18-3030 years + post cancer treatment; male; age at diagnosis 31-5030 years + post cancer treatment; male; age at diagnosis 51-7030 years + post cancer treatment; male; age at diagnosis 70+5-10 years post cancer treatment; female; age at diagnosis 18-305-10 years post cancer treatment; female; age at diagnosis 31-505-10 years post cancer treatment; female; age at diagnosis 51-705-10 years post cancer treatment; female; age at diagnosis 70+5-10 years post cancer treatment; male; age at diagnosis 18-305-10 years post cancer treatment; male; age at diagnosis 31-505-10 years post cancer treatment; male; age at diagnosis 51-705-10 years post cancer treatment; male; age at diagnosis 70+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Currently receiving any active cancer treatment
  • Interview study
  • 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
  • Currently receiving any active cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

LymphomaLeukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Central Study Contacts

Salina Tsui, MSc

CONTACT

+44 7726781196salina.tsui@nhs.net

Claire Higham, PhD

CONTACT

claire.higham2@nhs.net

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 19, 2023

Study Start

May 2, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)