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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 : Unknown
Verified April 2017 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Toronto General Hospital
University Health Network, Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Behavioral: Rehabilitation Consult (RC) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jorge Rios, HBSc 416-226-6780 ext 7450 jorge.rios@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre, Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jorge Rios, HBSc    416-226-6780 ext 7450    jorge.rios@sunnybrook.ca   
Principal Investigator: Sara McEwen, PhD         
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Colleen Dunphy       colleen.dunphy@uhn.ca   
Principal Investigator: Jolie Ringash, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Princess Margaret Hospital, Canada
Toronto General Hospital
University Health Network, Toronto
Investigators
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Principal Investigator: Sara McEwen, PhD Sunnybrook Research Institute, St. John's Rehab Program
More Information
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Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Publication of the initial project protocol
Clinical Study Report  This link exits the ClinicalTrials.gov site
Publication based on findings from focus groups used to create the intervention in this study

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02836769    
Other Study ID Numbers: 246-2013
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sunnybrook Health Sciences Centre:
Rehabilitation
Head and neck cancer
Quality of life
self-efficacy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms