Rehabilitation Planning Consult Phase II Trial (RPC-II)

Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase II Randomized Controlled Trial

The study will evaluate the efficacy of the Rehabilitation Planning Consult (RPC) to achieve key rehabilitation outcomes in survivors of head and neck cancer compared to a waiting list control group. The RPC is a consultative intervention that teaches survivors to use self-management and problem solving strategies to meet and attain individualized goals. Follow-through with plans and goal attainment are facilitated by a Rehabilitation Consultant. Results from this study will be used to plan for a larger multi-site trial and subsequent real world implementation.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Behavioral: Rehabilitation Planning Consult (RPC); Other: Wait list control (WLC)

Detailed Description

Survivors of head and neck cancer (HNC) often have significant impairments, functional limitations, and reduced quality of life (QL). Rehabilitation services, such as speech-language pathology to improve swallowing, physiotherapy to improve neck mobility, and occupational therapy to enable return to work, can effectively reduce the impact of impairments, restore function, and improve QL. However, access to rehabilitation for survivors of HNC is extremely limited. A trans-professional self-management program is needed to provide resources, links to community providers, and instruction in problem-solving strategies. The program should fit seamlessly into the cancer care system with minimal additional resources. To meet these specifications, an innovative intervention, the Rehabilitation Planning Consult (RPC), was developed and evaluated. The RPC is delivered in 1 to 2 sessions and, in a single arm pilot study, had a moderate to large effect on several aspects of QL and individualized goal attainment. It remains unknown whether the RPC is efficacious in comparison to standard care. In preparation for a Phase III trial, the effect of the RPC, as compared to a standard care control will be estimated, on HNC survivors' QL, attainment of individualized goals, and self-efficacy related to self-management. To facilitate recruitment and ensure ethical provision of services, participants will be randomized to a waiting list control (WLC) or RPC. Assessments will be conducted at three time points for the RPC group and four times for the WLC group. Based on pilot data, approximately 43% of the RPC group are expected to achieve a minimal important difference (MID) in QL, thus 56 participants per arm, 112 participants total, will be recruited. The primary outcome will be QL related to physical health, measured using the SF-36 Physical Component Summary Score (PCS). Secondary measures will include individualized goal performance measured using the Brief Rehabilitation Assessment for Survivors of HNC, disease-specific QL measured with the FACT-HN, and self-efficacy.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • 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:

• Survivor of head and neck cancer
• Completed treatment in the past 6 months

Exclusion Criteria:

• Cognitive issues
• Communication issues
• Presence of major comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation Planning Consult (RPC); The RPC is a trans-disciplinary, consultative intervention. In the RPC, individualized rehabilitation needs are established, goals are set, strategies to achieve the goals are developed, and follow-through with strategies and goal attainment is facilitated by a rehabilitation professional who consults and collaborates with the survivor. The Rehabilitation Consultant does not provide hands-on treatment, but rather determines the survivors' priority individualized rehabilitation goals, and then helps devise a plan for the survivor to meet those goals independently. Participants allocated to RPC will receive a 1 hour consultation with the Rehabilitation Consultant and second consultation 2 to 12 weeks later.	Behavioral: Rehabilitation Planning Consult (RPC); Participants allocated to RPC will receive a 1 hour consultation with the Rehabilitation Consult and second consultation over the next 12 weeks as needed. Participants will be assessed at three time points, 1) Baseline assessment, 1 week prior to RPC, 2) post-intervention assessment, 1 week after RPC, and 3) follow-up assessment, 13 weeks after RPC.; Other Names: RPC
Active Comparator: Wait list control (WLC); There is no standard rehabilitation care for survivors of head and neck cancer at the Princess Margaret Cancer Centre. Participants allocated to WLC will enter a 12 week waiting period after which they will crossover to the RPC group.	Behavioral: Rehabilitation Planning Consult (RPC); Participants allocated to RPC will receive a 1 hour consultation with the Rehabilitation Consult and second consultation over the next 12 weeks as needed. Participants will be assessed at three time points, 1) Baseline assessment, 1 week prior to RPC, 2) post-intervention assessment, 1 week after RPC, and 3) follow-up assessment, 13 weeks after RPC.; Other Names: RPC; Other: Wait list control (WLC); Participants who are allocated to WLC will complete a 12 week waiting period. At the end of the waiting period, participants will crossover to the RPC group. Participants will be assessed at four time points, 1) Baseline assessment, 1 week prior to waiting period, 2) post-waiting period assessment, 1 week after waiting period, 3) post-intervention assessment, 1 week after RPC, and 4) follow-up assessment,13 weeks after RPC.; Other Names: WLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the 36-Item Short Form Health Survey - Physical Composite Summary	The 36-Item Short Form Health Survey (SF-36) is a self-report generic quality of life measure. The SF-36 has eight domains with scores ranging from 0 to 100, higher scores indicate greater self-reported quality of life. The proportion of participants achieving minimal important difference on the Physical Composite Summary score in the RPC group and WLC group will be analyzed.	RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Assessment of Cancer Therapy - Head and Neck scores	The Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) is a self-report disease-specific quality of life measure. The FACT-H&N covers 5 domains of quality of life: a) physical well being (score range 0-28), b) social/family well being (score range 0-28), c) emotional well being (score range 0-24), d) functional well being (score range 0-28), and e) head and neck cancer subscale (score range 0-40). A total score can be calculated by adding the 5 subscale scores (total score range 0-148). Higher scores indicate greater better outcomes.	RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
Change in Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer scores	The Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer (BRASH) is a self-report measure of individualized goal performance. the measure has three domains, performance, satisfaction, and self-efficacy. Scores for each of the three domains range from 0 to 100, higher scores indicate better outcomes.	RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
Change in 36-Item Short Form Health Survey - Mental Composite Summary scores	The 36-Item Short Form Health Survey (SF-36) is a self-report generic quality of life measure. The SF-36 has eight domains with scores ranging from 0 to 100, higher scores indicate better outcomes. The Metal Composite Summary score will be analyzed.	RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Jolie Ringash, MD, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Self-management; Head and neck cancer; Rehabilitation planning consult
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 18-5930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No