Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer (HNC-RC)

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Behavioral: Rehabilitation Consult (RC)

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Odette Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)	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.	A) 1 week post-intervention, B) 1-2 months post intervention
Change in Medical Outcome Short Form (36) Health Survey - (SF-36)	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.	A) 1 week post-intervention, B) 1-2 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Goal Performance, Satisfaction, and Self-efficacy	Participants completed the Brief Rehabilitation Assessment for Survivors Of Head And Neck Cancer (BRASH), a self report tool where participants rate their current performance, satisfaction with self-selected rehab goals, and rate their confidence in their ability to achieve each goal. Higher scores indicate greater self-reported, performance, satisfaction, and self-efficacy. Scores for each of confidence, performance, and satisfaction can range from 0 to 100. Each category is then compared to itself and the change calculated by subtracting the earlier score from the latter.	A) 1 week post-intervention, B) 1-2 months post intervention

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: University Health Network, Toronto; Princess Margaret Hospital, Canada; Toronto General Hospital
• Investigators: Principal Investigator: Sara McEwen, PhD, Sunnybrook Research Institute, St. John's Rehab Program

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of life; Head and neck cancer; self-efficacy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 246-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information comments: Publication of the initial project protocol
2. Clinical Study Report
   Information comments: Publication based on findings from focus groups used to create the intervention in this study