Head and Neck NeoplasmsRPC-IINCT03672799
Rehabilitation Planning Consult Phase II Trial
A study testing Rehabilitation Planning Consult (RPC) in people with Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Rehabilitation Planning Consult (RPC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2019to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivor of head and neck cancer
- Completed treatment in the past 6 months
Who cannot join
- Cognitive issues
- Communication issues
- Presence of major comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Rehabilitation Planning Consult (RPC), Wait list control (WLC)
- Keywords
- Head and neck cancer, Rehabilitation, Rehabilitation planning consult, Self-management
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Planning Consult (RPC)Behavioural
Also called 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.
Wait list control (WLC)Other
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Rehabilitation Planning Consult (RPC); Other: Wait list control (WLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: RPC: 1) 1 week pre-intervention; 2) 1 week post intervention; WLC: 1) 1 week pre-waiting period; 2) 1 week post-waiting period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start7 Jan 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial with two arms, the experimental arm (Rehabilitation Planning Consult; RPC) and a wait list control (WLC) arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolie Ringash, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672799
- Sponsor's protocol ID
- 18-5930
- Acronym
- RPC-II
- Status last verified
- Jul 2021
- First submitted
- 12 Sep 2018
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ringash J, Dunphy C, Avery L, Chahin R, Chang E, Davis AM, Jones J, Martino R, Moody L, Giuliani M, McEwen S. Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):759-769. doi: 10.1016/j.ijrobp.2023.09.042. Epub 2023 Oct 9.
PubMed 37820770
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03672799
- Acronym / sponsor ID
- RPC-II / 18-5930
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and neck cancer, Rehabilitation, Rehabilitation planning consult, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two arms, the experimental arm (Rehabilitation Planning Consult; RPC) and a wait list control (WLC) arm.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Planning Consult (RPC) | Experimental | Behavioral: 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. |
| Wait list control (WLC) | Active comparator | Behavioral: Rehabilitation Planning Consult (RPC), Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Survivor of head and neck cancer
- Completed treatment in the past 6 months
Key exclusion criteria (3 listed)
- Cognitive issues
- Communication issues
- Presence of major comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation Planning Consult (RPC)Also: RPCParticipants 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. | Behavioural | Rehabilitation Planning Consult (RPC), Wait list control (WLC) |
| Wait list control (WLC)Also: WLCParticipants 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 | Wait list control (WLC) |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 37820770Ringash J, Dunphy C, Avery L, Chahin R, Chang E, Davis AM, Jones J, Martino R, Moody L, Giuliani M, McEwen S. Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):759-769. doi: 10.1016/j.ijrobp.2023.09.042. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolie Ringash, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Planning Consult (RPC) in people with Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.