Clinical trial NCT02836769: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Rehabilitation
Head and neck cancer
Quality of life
self-efficacy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: Toronto General Hospital
name: University Health Network, Toronto
First posted: 2016-07-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)
timeFrame: A) 1 week post-intervention, B) 1-2 months post intervention
measure: Change in Medical Outcome Short Form (36) Health Survey - (SF-36)
timeFrame: A) 1 week post-intervention, B) 1-2 months post intervention
Secondary outcomes:
measure: Change in Goal Performance, Satisfaction, and Self-efficacy
timeFrame: A) 1 week post-intervention, B) 1-2 months post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute, St. John's Rehab Program
name: Sara McEwen, PhD
role: PRINCIPAL_INVESTIGATOR
References: