A randomised controlled clinical feasibility trial to determine the feasibility and acceptability of a "musculoskeletal health package (MHP)" intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and inform power calculations for a definitive trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
3 month prehabilitation exercise program during radiotherapy with assessment of BMD at baseline with appropriate management according to fracture risk assessment (with either (a) lifestyle advice, (b) calcium and vitamin D (c) calcium, vitamin D and bisphosphonate (alendronate))
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom
Eligibility and screening rate
proportion of patients eligible for the study from the patient population
Time frame: baseline
Recruitment and study group allocation rate
number of eligible patients recruited, randomised and allocated to appropriate study populations
Time frame: 2 weeks post consent
Recruitment and study group allocation rate
proportion of eligible patients recruited, randomised and allocated to appropriate study populations
Time frame: 2 weeks post consent
Intervention fidelity rate
number of patients completing the elements of the study
Time frame: end of study 18 months
Intervention fidelity rate
proportion of patients completing the elements of the study
Time frame: end of study 18 months
Attrition rate
number of patients lost to follow-up
Time frame: end of study 18 months
Patient and physician acceptability y
Patient and physician acceptability assessed with electronic questionnaires
Time frame: change from baseline to 6 months
Patient and physician acceptability y
Patient and physician acceptability assessed with electronic questionnaires
Time frame: change from baseline to 12 months
Patient and physician acceptability y
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Patient and physician acceptability assessed with electronic questionnaires
Time frame: change from baseline to 18 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Time frame: change from baseline to 6 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Time frame: change from baseline to 12 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Time frame: change from baseline to 18 months
Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)
Incidence of RRIF assessed by MR
Time frame: assessed at 6, 12 , 18 months post radiotherapy
Longitudinal change in BMD
BMD measured by DXA at baseline and 18 months
Time frame: assessed at baseline and 18 months
Longitudinal change in fracture risk using FRAX (inc BMD by DXA)
FRAX assessment tool (including femoral neck BMD)
Time frame: assessed at baseline and 18 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 2
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 3
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 4
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 5
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 6
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 7
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 8
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to week 9
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to 6 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to 12 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Time frame: change from baseline to 18 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)
Time frame: change from baseline to 6 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)
Time frame: change from baseline to 12 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)
Time frame: change from baseline to 18 months
Quality of Life Assessment: SMFA adapted to lower limbs
adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)
Time frame: change from baseline to 6 months
Quality of Life Assessment: SMFA adapted to lower limbs
adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)
Time frame: change from baseline to 12 months
Quality of Life Assessment: SMFA adapted to lower limbs
adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)
Time frame: change from baseline to 18 months