Rehabilitation Planning Consult Phase II Trial

NCT ID: NCT03672799

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2021-07-07

Brief Summary

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.

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation Planning Consult (RPC)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation Planning Consult (RPC)

Intervention Type: BEHAVIORAL

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.

Wait list control (WLC)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

RPC; WLC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolie Ringash, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

18-5930

Identifier Type: -

Identifier Source: org_study_id