Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer (HNC-RC)
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|ClinicalTrials.gov Identifier: NCT02836769|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Behavioral: Rehabilitation Consult (RC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Pilot Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Experimental: Rehabilitation Consult (RC)
Pilot testing: single group pre-post design
Behavioral: Rehabilitation Consult (RC)
The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.
- Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N) [ Time Frame: A) 1 week post-intervention, B) 1-2 months post intervention ]quality of life questionnaire
- Change in Medical Outcome Short Form (36) Health Survey - (SF-36) [ Time Frame: A) 1 week post-intervention, B) 1-2 months post intervention ]quality of life questionnaire
- Change in goal performance, satisfaction, and self-efficacy [ Time Frame: A) 1 week post-intervention, B) 1-2 months post intervention ]Participants will be asked to rank their current performance with each self-selected goal, current satisfaction with their goal performance, and confidence in their ability to achieve the goal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836769
|Contact: Jorge Rios, HBSc||416-226-6780 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre, Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Jorge Rios, HBSc 416-226-6780 ext 7450 email@example.com|
|Principal Investigator: Sara McEwen, PhD|
|University Health Network, Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Colleen Dunphy firstname.lastname@example.org|
|Principal Investigator: Jolie Ringash, MD|
|Principal Investigator:||Sara McEwen, PhD||Sunnybrook Research Institute, St. John's Rehab Program|