Musculoskeletal Health in Adult Haematological Cancer Survivors (SKETCh)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Leukemia; Cancer Survivors; Musculoskeletal Complication
• Intervention / Treatment: Other: Not an intervention study

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Salina Tsui, MSc; Phone Number: +44 7726781196; Email: salina.tsui@nhs.net
• Study Contact Backup: Name: Claire Higham, PhD; Email: claire.higham2@nhs.net

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
    • Contact: Salina Tsui; Phone Number: 07726781196; Email: salina.tsui@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

32

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
5-10 years post cancer treatment; male; age at diagnosis 18-30	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.
5-10 years post cancer treatment; male; age at diagnosis 31-50	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.
5-10 years post cancer treatment; male; age at diagnosis 51-70	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.
5-10 years post cancer treatment; male; age at diagnosis 70+	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.
5-10 years post cancer treatment; female; age at diagnosis 18-30	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.
5-10 years post cancer treatment; female; age at diagnosis 31-50	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.
5-10 years post cancer treatment; female; age at diagnosis 51-70	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.
5-10 years post cancer treatment; female; age at diagnosis 70+	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.
11-20 years post cancer treatment; male; age at diagnosis 18-30	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.
11-20 years post cancer treatment; male; age at diagnosis 31-50	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.
11-20 years post cancer treatment; male; age at diagnosis 51-70	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.
11-20 years post cancer treatment; male; age at diagnosis 70+	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.
11-20 years post cancer treatment; female; age at diagnosis 18-30	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.
11-20 years post cancer treatment; female; age at diagnosis 31-50	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.
11-20 years post cancer treatment; female; age at diagnosis 51-70	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.
11-20 years post cancer treatment; female; age at diagnosis 70+	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.
21-30 years post cancer treatment; male; age at diagnosis 18-30	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.
21-30 years post cancer treatment; male; age at diagnosis 31-50	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.
21-30 years post cancer treatment; male; age at diagnosis 51-70	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.
21-30 years post cancer treatment; male; age at diagnosis 70+	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.
21-30 years post cancer treatment; female; age at diagnosis 18-30	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.
21-30 years post cancer treatment; female; age at diagnosis 31-50	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.
21-30 years post cancer treatment; female; age at diagnosis 51-70	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.
21-30 years post cancer treatment; female; age at diagnosis 70+	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.
30 years + post cancer treatment; male; age at diagnosis 18-30	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.
30 years + post cancer treatment; male; age at diagnosis 31-50	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.
30 years + post cancer treatment; male; age at diagnosis 51-70	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.
30 years + post cancer treatment; male; age at diagnosis 70+	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.
30 years + post cancer treatment; female; age at diagnosis 18-30	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.
30 years + post cancer treatment; female; age at diagnosis 31-50	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.
30 years + post cancer treatment; female; age at diagnosis 51-70	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.
30 years + post cancer treatment; female; age at diagnosis 70+	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CFTsp167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No