Clinical trial NCT03672799: Rehabilitation Planning Consult Phase II Trial
Official title: Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Head and neck cancer
Rehabilitation
Rehabilitation planning consult
Self-management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial with two arms, the experimental arm (Rehabilitation Planning Consult; RPC) and a wait list control (WLC) arm.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in the 36-Item Short Form Health Survey - Physical Composite Summary
timeFrame: 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:
measure: Change in Functional Assessment of Cancer Therapy - Head and Neck scores
timeFrame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
measure: Change in Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer scores
timeFrame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
measure: Change in 36-Item Short Form Health Survey - Mental Composite Summary scores
timeFrame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Jolie Ringash, MD
role: PRINCIPAL_INVESTIGATOR
References: