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1.
Support Care Cancer ; 32(7): 479, 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38954025

ABSTRACT

PURPOSE: Continuous lenalidomide maintenance treatment after autologous stem cell transplantation delivers improvement in progression free and overall survival among newly diagnosed multiple myeloma patients and has been the standard of care in the UK since March 2021. However, there is scant information about its impact on patients' day-to-day lives. This service evaluation aimed to qualitatively assess patients receiving lenalidomide treatment at a cancer centre in London, in order that the service might better align with needs and expectations of patients. METHODS: We conducted 20 semi-structured interviews among myeloma patients who were on continuous lenalidomide maintenance treatment at a specialist cancer centre in London. Members of the clinical team identified potentially eligible participants to take part, and convenience sampling was used to select 10 male and 10 female patients, median age of 58 (range, 45-71). The median treatment duration was 11 months (range, 1-60 months). Participants were qualitatively interviewed following the same semi-structured interview guide, which was designed to explore patient experience and insights of lenalidomide. Reflexive thematic analysis was used for data analysis. RESULTS: Four overarching themes were as follows: (i) lenalidomide: understanding its role and rationale; (ii) reframing the loss of a treatment-free period to a return to normal life; (iii) the reality of being on lenalidomide: balancing hopes with hurdles; (iv) gratitude and grievances: exploring mixed perceptions of care and communication. Results will be used to enhance clinical services by tailoring communication to better meet patients' preferences when making treatment decisions. CONCLUSION: This study highlights that most patients feel gratitude for being offered continuous lenalidomide and perceive it as alleviating some fears concerning relapse. It reveals variations in side effects in different age groups; younger patients reported no/negligible side effects, whilst several older patients with comorbidities described significant symptom burden, occasionally leading to treatment discontinuation which caused distress at the perceived loss of prolonged remission. Future research should prioritise understanding the unique needs of younger patients living with multiple myeloma.


Subject(s)
Lenalidomide , Multiple Myeloma , Qualitative Research , Humans , Multiple Myeloma/drug therapy , Multiple Myeloma/psychology , Multiple Myeloma/therapy , Lenalidomide/therapeutic use , Lenalidomide/administration & dosage , Male , Female , Middle Aged , Aged , London , Maintenance Chemotherapy/methods , Interviews as Topic , Quality of Life , Transplantation, Autologous/methods , Antineoplastic Agents/therapeutic use , Antineoplastic Agents/administration & dosage
2.
Physiother Theory Pract ; : 1-13, 2023 Aug 09.
Article in English | MEDLINE | ID: mdl-37555437

ABSTRACT

BACKGROUND: Recruitment rates to rehabilitation trials are variable among cancer survivors, and deeper investigation into the causes for declining participation is needed. The aim of this study was to qualitatively explore the experiences of people with myeloma referred for autologous stem cell transplant who were approached to take part in a physiotherapist-led exercise trial but declined. METHODS: Participants were asked to participate in this qualitative study after declining to participate in a trial conducted at a UK tertiary cancer center. Semi-structured interviews were conducted. Data was analyzed inductively using reflexive thematic analysis. RESULTS: Interviews from 18 myeloma patients (56% male, mean age 62 years) were analyzed. Four themes were identified: 1) Traveling to the specialist center is challenging, not just logistically; 2) Individualized approach valued but recall of research information variable; 3) Being less active has profound impact yet ameliorative support is lacking; and 4) Common side-effects of treatment are expected and endured but personal impact underestimated and unaddressed. CONCLUSION: A number of barriers to participation were identified. Travel, a commonly cited reason for declining research participation, is more than a logistical issue for cancer survivors experiencing side-effects and the time burden of clinical appointments. Expectation or knowledge of the typical side-effects from myeloma and its treatment may lead to under-reporting of concerns to care providers, despite their impact upon daily activities and quality of life. Approaches used for research recruitment should consider the timing and consequences of ongoing cancer treatment to reduce potential barriers to participation.

3.
BMC Cancer ; 23(1): 348, 2023 Apr 17.
Article in English | MEDLINE | ID: mdl-37069548

ABSTRACT

BACKGROUND: The addition of qualitative methodology to randomised controlled trials evaluating complex interventions allows better understanding of contextualised factors and their potential influence on trial delivery and outcomes, as well as opportunities for feedback on trial participation to improve future trial protocols. This study explored the experiences of participation in cancer rehabilitation research during active cancer treatment. Participants were people living with haematological cancer myeloma, undergoing autologous stem cell transplantation (ASCT) recruited to the PERCEPT myeloma pilot trial. METHODS: A qualitative semi-structured interview study, embedded within a pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered before, during and after ASCT among people living with myeloma. Transcripts were analysed using reflexive thematic analysis. RESULTS: Interviews from 16 trial participants (n = 8 intervention group; n = 8 control group; mean age 61 years, 56% male) were analysed. Four main themes were identified: (1) "It's not just beneficial for me, it's for people after me as well"; (2) Disparities in experience of recovery - expectations, feeling prepared and support; (3) "What I wanted to do was build myself back up and prepare"; (4) Active ingredients - participants' experience of the trial intervention. Participants reported both altruistic and perceived personal gain as motivators for enrolling in the trial. Disappointment caused by allocation to control arm may have led to participants seeking exercise elsewhere, indicating possible contamination of control condition. Disparities in experience of recovery from transplant were evident with intervention participants reporting greater trajectory of recovery. CONCLUSIONS: The findings from this embedded qualitative study highlight numerous considerations required when designing pilot and efficacy trials of complex interventions. The addition of qualitative investigation offers greater understanding of motivations for participation, intervention mechanisms at play as well as effects of participation that may impact interpretation of quantitative outcomes. TRIAL REGISTRATION: Qualitative findings from a prospectively registered pilot trial (ISRCTN15875290), registered 13/02/2019.


Subject(s)
Hematopoietic Stem Cell Transplantation , Multiple Myeloma , Humans , Male , Middle Aged , Female , Multiple Myeloma/therapy , Preoperative Exercise , Transplantation, Autologous , Qualitative Research , Randomized Controlled Trials as Topic
4.
Acta Oncol ; 62(7): 696-705, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36794394

ABSTRACT

BACKGROUND: Autologous stem cell transplant (ASCT) is first line treatment for newly diagnosed patients with myeloma but often results in functional deficits and reduced quality of life (QOL). Physically active myeloma patients have better QOL, less fatigue and reduced morbidity. This trial aimed to investigate the feasibility of a physiotherapist-led exercise intervention delivered across the continuum of the myeloma ASCT pathway at a UK centre. Initially designed and delivered as a face-to-face trial, the study protocol was adapted to virtual delivery in response to the COVID-19 pandemic. MATERIAL AND METHODS: A pilot randomised controlled trial of a partly supervised exercise intervention with incorporated behaviour change techniques delivered before, during and for 3 months following ASCT compared to usual care. Face-to-face delivery of the pre-ASCT supervised intervention was adapted to virtually-supervised group classes via video conferencing. Primary outcomes related to feasibility; recruitment rate, attrition and adherence. Secondary outcomes included patient reported measures of QOL (EORTC C30, FACT-BMT, EQ5D), and fatigue (FACIT-F), measures of functional capacity (six-minute walk test (6MWT), timed sit-to-stand (TSTS), hand grip strength, self-reported and objective physical activity (PA). RESULTS: Over 11 months 50 participants were enrolled and randomised. Overall, uptake to the study was 46%. The attrition rate was 34%, mainly related to failure to undergo ASCT. Loss of follow-up for other reasons was low. Secondary outcomes demonstrate potential for the benefit of exercise prior to, during and after ASCT with improvements in QOL, fatigue, functional capacity and PA evident on admission for ASCT and 3 months post-ASCT. DISCUSSION: Results indicate acceptability and feasibility of delivering exercise prehabilitation, in person and virtually within the ASCT pathway in myeloma. The effects of prehabilitation and rehabilitation provision as a component of the ASCT pathway warrants further investigation.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Multiple Myeloma , Humans , Multiple Myeloma/therapy , Hematopoietic Stem Cell Transplantation/methods , Quality of Life , Preoperative Exercise , Hand Strength , Pandemics , Pilot Projects , Transplantation, Autologous , COVID-19/epidemiology , Stem Cell Transplantation , Exercise , Fatigue/etiology , Exercise Therapy/methods
5.
Support Care Cancer ; 31(2): 127, 2023 Jan 21.
Article in English | MEDLINE | ID: mdl-36680643

ABSTRACT

PURPOSE: Patients with multiple myeloma suffer from disease-related complications such as bone destruction, toxicities from repeated therapies and age-related co-morbidities. With improved treatment options, patients are living longer and have specific survivorship needs such as low exercise levels that need to be addressed. In this study, we designed, implemented and evaluated a multidisciplinary team (MDT) myeloma clinic that provided participants with tailored exercise and lifestyle advice. METHODS: The Promoting Individualised Self-Management and Survivorship (PrISMS) clinic was set up in two UK myeloma centres. This remote MDT clinic comprised of a doctor, a nurse specialist and a physiotherapist. Patients were required to complete blood tests and a questionnaire about their symptoms and concerns before each consultation. Patient-reported outcome measures were captured using validated questionnaires. Patient feedback was collected using a specially designed survey and structured telephone interviews. RESULTS: Sixty-one patients were enrolled in the pilot clinic with 210 consultations held during the study period. Nine patients had disease progression and were referred safely back to face-to-face clinics. There was a significant improvement in patients' exercise score (p = 0.02) after PrISMS clinic. Patient satisfaction was high, with 83% feeling more confident in self-managing myeloma after PrISMS clinic. CONCLUSION: PrISMS clinic is safe and feasible, with high patient compliant and acceptability. It empowers patients to self-manage their condition and encourages physical activity, which is associated with improved quality of life and fatigue level. Future randomised controlled trials will help to confirm its benefits on patient clinical outcomes and cost-effectiveness.


Subject(s)
Multiple Myeloma , Patient Satisfaction , Humans , Multiple Myeloma/therapy , Quality of Life , Exercise , Patient Care Team
6.
Support Care Cancer ; 30(9): 7469-7479, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35657402

ABSTRACT

Autologous stem cell transplantation (ASCT) is standard of care in biologically fit, newly diagnosed multiple myeloma (MM) patients, offering better therapeutic outcomes and improved quality of life (QoL). However, with the UK's 1st national lockdown on 23/03/2020, several guidelines recommended deferring ASCT due to risks of infection, with resource limitations forcing some units to suspend ASCT entirely. Such changes to patients' treatment plans inevitably altered their lived experience during these uncertain times with expected impact on QoL. We conducted a qualitative study using semi-structured interviews to gain insight into MM patients' understanding of their disease, initial therapy and ASCT, and their response to therapy changes. A clinical snapshot of how COVID-19 affected the MM ASCT service in a single UK institution is also provided, including changes to chemotherapy treatment plans, timing, and prioritisation of ASCT. Framework analysis identified 6 overarching themes: (1) beliefs about ASCT, (2) perceptions of information provided about MM and ASCT, (3) high levels of fear and anxiety due to COVID-19, (4) feelings about ASCT disruption or delay due to COVID-19, (5) perceptions of care, and (6) importance of social support. Example subthemes were beliefs that ASCT would provide a long-remission/best chance of normality including freedom from chemotherapy and associated side-effects, disappointment, and devastation at COVID-related treatment delays (despite high anxiety about infection) and exceptionally high levels of trust in the transplant team. Such insights will help us adjust our service and counselling approaches to be more in tune with patients' priorities and expectations.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Multiple Myeloma , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Communicable Disease Control , Humans , Multiple Myeloma/drug therapy , Quality of Life , Retrospective Studies , Stem Cell Transplantation , Transplantation, Autologous
7.
Support Care Cancer ; 30(7): 6273-6286, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35467117

ABSTRACT

PURPOSE: The Myeloma: Advancing Survival Cancer Outcomes Trial (MASCOT) tested the impact of a supervised exercise programme on fatigue, clinical, and patient-reported outcomes in multiple myeloma [MM] patients. The current study explored MM patients' experiences of the programme to guide future interventions. METHODS: Purposive sampling was used to recruit stable MM patients participating in MASCOT. Semi-structured, face-to-face interviews were conducted, transcribed verbatim, and analysed using thematic analysis. RESULTS: Six themes were identified. Key drivers for participation in MASCOT were "Altruism and extended cancer care"; participants wanted to give something back and assist in improving post-treatment care for MM patients, especially as after treatment "Barriers to being physically active" were a fear of damage and lack of health professional guidance. "Influences fostering change within the intervention" included physiotherapy supervision and tailored exercises, which gave participants confidence to push themselves in a safe environment and broke down misconceptions about their body. "Social support", from both family and peers in the programme, promoted motivation and adherence. Participants expressed concerns about "Maintaining things going forward" but had identified mechanisms to aid continuation. "Physical and mental benefits" of the programme were highlighted; participants were able to do things they couldn't before and described feeling free from the constraints of MM. CONCLUSIONS: A post-treatment exercise intervention for MM patients was a positive experience, which enhanced participants' physical and psychological wellbeing. Tailored gym and home-based exercises, a specialist cancer physiotherapist, and sustained support were perceived to be important for success. IMPLICATIONS FOR CANCER SURVIVORS: Exercise support for MM patients, ideally with physiotherapist supervision, should be incorporated into survivorship care to qualitatively improve patients' quality of life, self-efficacy, and mental wellbeing.


Subject(s)
Multiple Myeloma , Exercise , Exercise Therapy , Humans , Multiple Myeloma/therapy , Qualitative Research , Quality of Life
8.
Pilot Feasibility Stud ; 8(1): 91, 2022 Apr 25.
Article in English | MEDLINE | ID: mdl-35468872

ABSTRACT

BACKGROUND: The use of lumbar fusion surgery is increasing in developed economies. High levels of patient dissatisfaction are reported post-operatively. To address this need, we developed a theoretically informed rehabilitation programme for use following lumbar fusion surgery (the REFS programme). We conducted a mixed methods randomised controlled feasibility study (REFS v 'usual care'). The numerical and feasibility outcomes are reported separately. The current qualitative study was 'nested' within the main feasibility study to explore participants' experiences before and after lumbar fusion surgery including the impact of rehabilitation content. This facilitated a deeper understanding of potential mechanisms of action, for theoretical and programme refinement. METHODS: A purposive sample (n = 10 'usual care', n = 10 REFS) was identified from the main feasibility study cohort. Individual semi-structured interviews were conducted post-operatively (median 8 months, range 5-11). Interview data were transcribed verbatim, coded, and analysed thematically. RESULTS: Three themes were constructed: the breadth and severity of impact associated with a chronic lumbar disorder was summarised in theme 1, 'Ever-decreasing circles; living with a chronic lumbar disorder'. Theme 2, 'What have I done? Reflections on recovery from lumbar fusion surgery', illustrated participants post-operative helplessness, which was associated with worsening mental health, problematic use of opioids, fear related to the instillation of metalware, and the important mitigating effect of informal social support. Theme 3 'Rehabilitation experiences' identified critical rehabilitation programme content including exercise, a shared rehabilitation experience, the opportunity for vicarious learning, and professional expertise. CONCLUSIONS: To enhance patient benefit future REFS programme iterations should consider reinforcement of the identified valued programme content. Additional content should be considered to mitigate post-operative fear, which frequently aligned with the instillation of metalware into the spine. Participant's perceptions regarding the necessity of lumbar fusion surgery has potential implications for the surgical consent process. TRIAL REGISTRATION: Study registration; ISRCTN60891364 , date registered 10/7/2014.

9.
BMJ Open ; 12(4): e059516, 2022 04 08.
Article in English | MEDLINE | ID: mdl-35396313

ABSTRACT

INTRODUCTION AND OBJECTIVE: Research activity was impacted by the novel COVID-19 pandemic, the PERCEPT myeloma trial was no exception. This pilot randomised trial delivered a face-to-face exercise intervention prior to and during autologous stem cell transplantation (ASCT) in myeloma patients, as a consequence of COVID-19 it required significant adaptions to continue. This brief communication describes how the previously published study protocol was adapted for virtual delivery. In addition, we highlight the challenge of continuing the study which was embedded within a clinical pathway also impacted by the pandemic. SUMMARY: The original trial protocol was amended and continued to recruit and deliver an exercise prehabilitation intervention virtually. Continued delivery of the intervention was deemed important to participants already enrolled within the trial and the adapted virtual version of the trial was acceptable to the research ethics committee as well as participants. Development of effective, remotely delivered rehabilitation and physical activity programmes are likely to benefit people living with myeloma. The COVID-19 pandemic provided an opportunity to explore the feasibility of a virtual programme for ASCT recipients, however, continued changes to the clinical pathway within which the study was embedded posed the greatest challenge and ultimately led to early termination of recruitment. TRIAL REGISTRATION NUMBER: ISRCTN15875290; pre-results.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Multiple Myeloma , COVID-19/prevention & control , Hematopoietic Stem Cell Transplantation/methods , Humans , Multiple Myeloma/rehabilitation , Pandemics/prevention & control , Preoperative Exercise , Randomized Controlled Trials as Topic , Transplantation, Autologous
10.
J Multidiscip Healthc ; 14: 1659-1671, 2021.
Article in English | MEDLINE | ID: mdl-34234453

ABSTRACT

PURPOSE: Health professionals' (HPs) knowledge of recommended guidelines for physical activity (PA) is thought to influence the advice they provide to their patients. Little is known about the knowledge or provision of PA advice by HPs working with haematological cancer patients. This study examined awareness of PA guidance, beliefs and practices in provision of advice given by UK HPs working with haematological cancer patients. METHODS: Online survey including questions on awareness of PA guidance, levels of agreement/disagreement with statements related to PA in haematological cancer and reported provision of advice in practice. Open text responses sought detail regarding guidance knowledge and exampled advice given by respondents. Predictors of familiarity of guidance and provision of advice were examined. RESULTS: Complete responses were received from 156 professionals, mostly nurses, allied HPs and doctors. Many (31%) reported knowing relevant guidance and nearly half (48.6%) reported routinely giving PA advice. Nurses and allied AHPs give advice to more patients than doctors and knowledge of guidelines among doctors was poor. CONCLUSION: Beliefs of haematology professionals regarding the role of PA during and after treatment for haematological cancer were generally positive. Those reporting familiarity with guidance were more likely to give advice. Misalignment exists between guidelines and advice given by professionals to their patients. Increasing knowledge of guidelines among HPs, including nurses, may lead to increased provision of PA advice and promotion of PA to more of their patients. HPs education in haematology on PA guidance tailored to professional group is needed.

11.
BMC Res Notes ; 14(1): 171, 2021 May 07.
Article in English | MEDLINE | ID: mdl-33962674

ABSTRACT

OBJECTIVE: Physical activity has been shown to improve quality of life in cancer patients with some evidence in multiple myeloma. This study aimed to determine myeloma patients' exercise levels, their perception of physical activity, and to explore correlations with quality of life. Myeloma outpatients were invited to complete a number of questionnaires, including the Godin leisure-time exercise questionnaire (GLTEQ) to determine their exercise levels, the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire to assess health related quality of life, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire to assess fatigue. RESULTS: Of the 65 respondents, 75% would like to increase their exercise level. Weakness, fatigue and pain were the most commonly perceived barriers to physical activity. 59% would like to receive physical activity advice. Only 25% were deemed active based on their GLTEQ scores. Finally, there was a significant positive correlation between the GLTEQ score and the FACT-G score (p < 0.001). Results highlight an unmet exercise need in myeloma patients. Current practice should be reviewed to develop a more holistic care model that incorporates tailored exercise advice or programme.


Subject(s)
Multiple Myeloma , Exercise , Fatigue , Humans , Leisure Activities , Multiple Myeloma/therapy , Quality of Life , Surveys and Questionnaires
12.
Front Surg ; 8: 628848, 2021.
Article in English | MEDLINE | ID: mdl-33816546

ABSTRACT

Objectives: This systematic review set out to identify, evaluate and synthesise the evidence examining the effect of prehabilitation including exercise on postoperative outcomes following abdominal cancer surgery. Methods: Five electronic databases (MEDLINE 1946-2020, EMBASE 1947-2020, CINAHL 1937-2020, PEDro 1999-2020, and Cochrane Central Registry of Controlled Trials 1991-2020) were systematically searched (until August 2020) for randomised controlled trials (RCTs) that investigated the effects of prehabilitation interventions in patients undergoing abdominal cancer surgery. This review included any form of prehabilitation either unimodal or multimodal that included whole body and/or respiratory exercises as a stand-alone intervention or in addition to other prehabilitation interventions (such as nutrition and psychology) compared to standard care. Results: Twenty-two studies were included in the systematic review and 21 studies in the meta-analysis. There was moderate quality of evidence that multimodal prehabilitation improves pre-operative functional capacity as measured by 6 min walk distance (Mean difference [MD] 33.09 metres, 95% CI 17.69-48.50; p = <0.01) but improvement in cardiorespiratory fitness such as preoperative oxygen consumption at peak exercise (VO2 peak; MD 1.74 mL/kg/min, 95% CI -0.03-3.50; p = 0.05) and anaerobic threshold (AT; MD 1.21 mL/kg/min, 95% CI -0.34-2.76; p = 0.13) were not significant. A reduction in hospital length of stay (MD 3.68 days, 95% CI 0.92-6.44; p = 0.009) was observed but no effect was observed for postoperative complications (Odds Ratio [OR] 0.81, 95% CI 0.55-1.18; p = 0.27), pulmonary complications (OR 0.53, 95% CI 0.28-1.01; p = 0.05), hospital re-admission (OR 1.07, 95% CI 0.61-1.90; p = 0.81) or postoperative mortality (OR 0.95, 95% CI 0.43-2.09, p = 0.90). Conclusion: Multimodal prehabilitation improves preoperative functional capacity with reduction in hospital length of stay. This supports the need for ongoing research on innovative cost-effective prehabilitation approaches, research within large multicentre studies to verify this effect and to explore implementation strategies within clinical practise.

13.
Br J Cancer ; 123(2): 187-195, 2020 07.
Article in English | MEDLINE | ID: mdl-32435057

ABSTRACT

BACKGROUND: Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction. METHODS: In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue. RESULTS: During 2014-2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: -1.1-4.3]) or 6 months (0.3 [95% CI: -2.6-3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3-3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: -0.6-13.3]). There were no serious adverse events. CONCLUSIONS: Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue. CLINICAL TRIAL REGISTRATION: The study was registered with ISRCTN (38480455) and is completed.


Subject(s)
Exercise Therapy/methods , Multiple Myeloma/therapy , Physical Fitness/physiology , Adult , Aged , Aged, 80 and over , Cancer Survivors , Cohort Studies , Exercise Therapy/adverse effects , Fatigue/etiology , Fatigue/physiopathology , Female , Humans , Male , Middle Aged , Multiple Myeloma/complications , Multiple Myeloma/physiopathology , Quality of Life , Survivors
14.
J Clin Epidemiol ; 125: 76-83, 2020 09.
Article in English | MEDLINE | ID: mdl-32289352

ABSTRACT

OBJECTIVES: We used a method rarely seen in cancer behavioral trials to explore methods of overcoming difficulties often seen in randomized controlled trials. We report our experiences of the adapted Zelen design, so that other researchers can consider this approach for behavioral trials. STUDY DESIGN AND SETTING: The adapted Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life, and physical outcomes. All participants consented to an observational cohort study of lifestyle factors but were unaware of subsequent randomization to remain in cohort only group or be offered an exercise intervention requiring second consent. RESULTS: There was lower than expected uptake to the exercise offered group (57%), so the length of recruitment increased from 24 to 29 months to ensure power was reached. At enrollment, patients were unaware of the potential increased commitment, and as a result, 62% of participants allocated to the intervention declined because of the extra time/travel commitment required. This emulates clinical settings and suggests improvements in intervention delivery are required. Our findings suggest that the adapted Zelen design may be useful in limiting dropout of controls due to dissatisfaction from group allocation, or contamination of control arm. CONCLUSION: Future use of this design warrants careful consideration of the study resources and recruitment time frames required but holds potential value in reducing contamination, control group dissatisfaction, and resulting dropout. Adapted Zelen design reduces selection bias and therefore gives clinicians a better understanding of acceptability in clinical settings. Future studies should evaluate control group experiences of the design and formally record contamination throughout the study to confirm its acceptability.


Subject(s)
Cancer Survivors/psychology , Exercise Therapy/methods , Multiple Myeloma/rehabilitation , Quality of Life/psychology , Cohort Studies , Feasibility Studies , Female , Humans , Informed Consent , Male , Multiple Myeloma/psychology , Patient Satisfaction , Patient Selection , Random Allocation , Research Design
15.
BMJ Open ; 10(1): e033176, 2020 01 29.
Article in English | MEDLINE | ID: mdl-32001493

ABSTRACT

INTRODUCTION: Myeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre. METHODS AND ANALYSIS: PERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6-8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models. ETHICS AND DISSEMINATION: This study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings. TRIAL REGISTRATION NUMBER: ISRCTN15875290.


Subject(s)
Exercise Therapy/methods , Hematopoietic Stem Cell Transplantation/methods , Multiple Myeloma/therapy , Preoperative Exercise , Quality of Life , Adult , Female , Humans , Male , Middle Aged , Pilot Projects , Transplantation, Autologous
16.
BMJ Open ; 5(11): e009576, 2015 Nov 27.
Article in English | MEDLINE | ID: mdl-26614625

ABSTRACT

OBJECTIVES: Multiple myeloma is the second most common haematological cancer. A growing body of literature is emerging that investigates the role physical activity plays in all stages of multiple myeloma (prevention and survivorship) and to date no attempt has been made to collate and understand this literature. Therefore, this scoping review aims to (1) outline what is already known about physical activity in all stages of multiple myeloma (2) map the literature on physical activity and multiple myeloma and (3) identify future directions for research. DESIGN: Scoping Review. DATA SOURCES: Searches were carried out in May 2015. Searchers were conducted in PubMed, Web of Science, SPORTdiscus and MEDLINE. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: To be included studies had to report original data, investigate physical activity per se or physical activity correlates and multiple myeloma or smouldering multiple myeloma. RESULTS: A total of 19 papers received full screening, 5 of these papers were excluded. This review identified three journal articles relating to the role of physical activity in the prevention of multiple myeloma, nine papers were identified in the treatment of multiple myeloma and two on smouldering multiple myeloma. CONCLUSIONS: The search identified that the literature surrounding multiple myeloma and physical activity is very limited. We encourage those designing new cohort studies to allow for future assessment of associations between physical activity and onset of multiple myeloma and smouldering multiple myeloma, as well as the potential role that physical activity plays in the progression from smouldering multiple myeloma to multiple myeloma. Second, we encourage the design and investigation of gender and treatment-specific physical activity interventions in patients with multiple myeloma. Finally, we highlight the need for more randomised controlled trials to evaluate the impact of different types, frequencies and intensities of physical activity on various health parameters in multiple myeloma survivors.


Subject(s)
Exercise , Multiple Myeloma/epidemiology , Humans , Multiple Myeloma/prevention & control , Randomized Controlled Trials as Topic
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