SKETCh: Musculoskeletal Health in Adult Haematological Cancer Survivors

Sponsor
The Christie NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05865678
Collaborator
National Institute for Health Research, United Kingdom (Other)
650
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Not an intervention study

Study Design

Study Type:
Observational
Anticipated Enrollment :
650 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Musculoskeletal Health in Adult Haematoloigcal Cancer Survivors - a Mixed Methods Study
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

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

  2. 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 [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.

  3. Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors [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).

  4. Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors [overall length of the study - 6 months]

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

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

Secondary Outcome Measures

  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]

    This will be assessed using regression analysis to determine risk factors that may be associated with poor musculoskeletal health

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05865678
Other Study ID Numbers:
  • CFTsp167
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 19, 2023