Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

Official Title

Development and Pilot Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

Summary:

Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.

Trial Description

Primary Outcome:

  • Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)
  • Change in Medical Outcome Short Form (36) Health Survey - (SF-36)
Secondary Outcome:
  • Change in goal performance, satisfaction, and self-efficacy
A RC for survivors of head and neck cancer (HNC) was developed in collaboration with an Advisory Panel that includes survivors, family members, health care professionals, and health system representatives. This phase of the study aims to conduct a pilot evaluation of the RC using a mixed method, single group study with a convenience sample of approximately 35 survivors of HNC post primary cancer treatment, recruited from the Princess Margaret Cancer Centre HNC clinics. In addition to the RC intervention, participants will be required to attend 3 research assessments (pre intervention, post intervention, and 1 month follow-up) that are a combination of face-to-face visits and telephone calls. Quantitative data analysis will be exploratory and descriptive, and effect sizes will be calculated for all outcomes to help plan for a future, controlled trial. Means, standard deviations, and Cohen's d effect size will be calculated for normally distributed data. For non-normally distributed data, medians, ranges, and a nonparametric effect size r will be calculated. For qualitative analysis, all interviews will be audio recorded, transcribed verbatim, and analyzed using a two-phased, hybrid approach that is both deductive and inductive. Findings will be summarized and reported to the Advisory Panel, who will then make recommendations regarding any additional modifications to the RC. The research team will make final decisions about RC modifications and will finalize a version for future evaluation.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society