Resumen
Este estudio se realizó en el marco de un ensayo clínico piloto que evaluó una intervención de ejercicio dirigida por fisioterapeutas en pacientes con mieloma múltiple sometidos a trasplante de células madre autólogas.
El estudio incluyó entrevistas cualitativas con 16 participantes para explorar su experiencia de participación en el ensayo.
Los resultados destacan la importancia de considerar los motivos de los pacientes para participar en los ensayos clínicos, la necesidad de abordar las disparidades en la experiencia de recuperación y la importancia de la intervención en sí misma.
Los fisioterapeutas deben tener en cuenta estos factores al diseñar futuros ensayos clínicos y al proporcionar atención a pacientes con mieloma múltiple sometidos a trasplante de células madre autólogas.
Mejorando los servicios fisioterapéuticos a través de la investigación cualitativa
Fisioterapeutas especializados en el ámbito clínico pueden ver un gran beneficio al incorporar enfoques cualitativos en sus protocolos de investigación. La aplicación de la investigación cualitativa en ensayos clínicos puede contribuir significativamente a la mejora de los servicios fisioterapéuticos ofrecidos en las clínicas, lo que conlleva a un mayor bienestar de los pacientes y una atención más personalizada.
Abstract original
"What I wanted to do was build myself back up and prepare": qualitative findings from the PERCEPT trial of prehabilitation during autologous stem cell transplantation in myeloma
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.
| Autores | Orla McCourt Abigail Fisher Joanne Land Gita Ramdharry Anna L Roberts Georgios Bekris Kwee Yong |
| revista | BMC Cancer |
| DOI | 10.1186/s12885-023-10799-1 |