跳至主要内容
临床试验/NCT02836769
NCT02836769已完成不适用

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

Sunnybrook Health Sciences Centre4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
4
主要终点
Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)

研究概览

简要总结

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.

详细描述

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 Center 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.

排除标准

  • Lack of English fluency,
  • Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and
  • Known active cancer.

结局指标

主要结局

Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)

时间窗: A) 1 week post-intervention, B) 1-2 months post intervention

Cancer-specific self-report measure of quality of life, higher scores indicate higher self-reported quality of life. Scores can range from 0 to 148. Changes in overall score as well as subsets will be evaluated for evidence of impact of intervention.

Change in Medical Outcome Short Form (36) Health Survey - (SF-36)

时间窗: A) 1 week post-intervention, B) 1-2 months post intervention

Self-report quality of life questionnaire. Higher scores indicate a higher self-reported quality of life. The Physical Composite Score (PCS) and the Mental Composite Score (MCS) are reported. Scores range from 0 to 100 for each individual item on the scale. These scores are then converted into composite totals based on the scoring system provided with the outcome measure.

次要结局

  • Change in Goal Performance, Satisfaction, and Self-efficacy(A) 1 week post-intervention, B) 1-2 months post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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