Rehabilitation Planning Consult Phase II Trial (RPC-II)
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ClinicalTrials.gov Identifier: NCT03672799 |
Recruitment Status :
Completed
First Posted : September 14, 2018
Last Update Posted : July 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Neoplasms | Behavioral: Rehabilitation Planning Consult (RPC) Other: Wait list control (WLC) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomized controlled trial with two arms, the experimental arm (Rehabilitation Planning Consult; RPC) and a wait list control (WLC) arm. |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | The outcomes assessor, study investigators, and statistician will remain blinded to group allocation. Participants and the treating therapist (Rehabilitation Consultant) will remain unblinded. |
Primary Purpose: | Supportive Care |
Official Title: | Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase II Randomized Controlled Trial |
Actual Study Start Date : | January 7, 2019 |
Actual Primary Completion Date : | July 7, 2021 |
Actual Study Completion Date : | July 7, 2021 |

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 Name: 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 Name: 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 Name: WLC |
- Change in the 36-Item Short Form Health Survey - Physical Composite Summary [ Time Frame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period. ]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.
- Change in Functional Assessment of Cancer Therapy - Head and Neck scores [ Time Frame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period. ]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.
- Change in Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer scores [ Time Frame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period. ]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.
- Change in 36-Item Short Form Health Survey - Mental Composite Summary scores [ Time Frame: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period. ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672799
Canada, Ontario | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada |
Principal Investigator: | Jolie Ringash, MD | Princess Margaret Cancer Centre |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT03672799 |
Other Study ID Numbers: |
18-5930 |
First Posted: | September 14, 2018 Key Record Dates |
Last Update Posted: | July 13, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Head and neck cancer Rehabilitation Rehabilitation planning consult Self-management |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |