Rehabilitation Planning Consult Phase II Trial

NCT03672799 | Completed

• 1 other identifier: 18-5930
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

Head and neck cancer; Rehabilitation; Rehabilitation planning consult; Self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Functional Assessment of Cancer Therapy - Head and Neck scores

  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

  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

  RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.

Study Arms (2)

Rehabilitation Planning Consult (RPC)

EXPERIMENTAL

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)

Wait list control (WLC)

ACTIVE COMPARATOR

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); Other: Wait list control (WLC)

Interventions

Rehabilitation Planning Consult (RPC) 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.

Also known as: RPC

Rehabilitation Planning Consult (RPC); Wait list control (WLC)

Wait list control (WLC) 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.

Also known as: WLC

Wait list control (WLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive issues
• Communication issues
• Presence of major comorbidities

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jolie Ringash, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor, study investigators, and statistician will remain blinded to group allocation. Participants and the treating therapist (Rehabilitation Consultant) will remain unblinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two arms, the experimental arm (Rehabilitation Planning Consult; RPC) and a wait list control (WLC) arm.

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: January 7, 2019
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

CA (1)