Rehabilitation Planning Consult Phase II Trial

Titre officiel

Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase II Randomized Controlled Trial

Sommaire:

L’étude évaluera l’efficacité des consultations de planification de la réadaptation en déterminant si celles-ci permettent aux survivants du cancer de la tête et du cou d’atteindre les principaux résultats en matière de réadaptation comparativement à un groupe de sujets témoins inscrits à une liste d’attente. La consultation de planification de la réadaptation est une intervention axée sur la consultation ayant pour but d’enseigner aux survivants des stratégies de prise en charge personnelle et de résolution de problèmes pour atteindre des objectifs personnalisés. Un conseiller en réadaptation assurera le suivi du plan de réadaptation et de l’atteinte des objectifs. Les résultats de cette étude serviront à planifier un essai multicentrique de plus grande envergure et sa mise en œuvre subséquente en contexte réel.

Description de l'essai

Primary Outcome:

  • Change in the 36-Item Short Form Health Survey - Physical Composite Summary
Secondary Outcome:
  • Change in Functional Assessment of Cancer Therapy - Head and Neck scores
  • Change in Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer scores
  • Change in 36-Item Short Form Health Survey - Mental Composite Summary scores
Survivors of head and neck cancer (HNC) often have significant impairments, functional limitations, and reduced quality of life (QL). Rehabilitation services, such as speech-language pathology to improve swallowing, physiotherapy to improve neck mobility, and occupational therapy to enable return to work, can effectively reduce the impact of impairments, restore function, and improve QL. However, access to rehabilitation for survivors of HNC is extremely limited. A trans-professional self-management program is needed to provide resources, links to community providers, and instruction in problem-solving strategies. The program should fit seamlessly into the cancer care system with minimal additional resources. To meet these specifications, an innovative intervention, the Rehabilitation Planning Consult (RPC), was developed and evaluated. The RPC is delivered in 1 to 2 sessions and, in a single arm pilot study, had a moderate to large effect on several aspects of QL and individualized goal attainment. It remains unknown whether the RPC is efficacious in comparison to standard care. In preparation for a Phase III trial, the effect of the RPC, as compared to a standard care control will be estimated, on HNC survivors' QL, attainment of individualized goals, and self-efficacy related to self-management. To facilitate recruitment and ensure ethical provision of services, participants will be randomized to a waiting list control (WLC) or RPC. Assessments will be conducted at three time points for the RPC group and four times for the WLC group. Based on pilot data, approximately 43% of the RPC group are expected to achieve a minimal important difference (MID) in QL, thus 56 participants per arm, 112 participants total, will be recruited. The primary outcome will be QL related to physical health, measured using the SF-36 Physical Component Summary Score (PCS). Secondary measures will include individualized goal performance measured using the Brief Rehabilitation Assessment for Survivors of HNC, disease-specific QL measured with the FACT-HN, and self-efficacy.

Voir cet essai sur ClinicalTrials.gov

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Ressources

Société canadienne du cancer

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