An interventional study of Rehabilitation Consult (RC) in Head and Neck Neoplasms, sponsored by Sunnybrook Health Sciences Centre. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.
A RC for survivors of head and neck cancer (HNC) was developed in collaboration with an Advisory Panel that includes survivors, family members, health care professionals, and health system representatives. This phase of the study aims to conduct a pilot evaluation of the RC using a mixed method, single group study with a convenience sample of approximately 35 survivors of HNC post primary cancer treatment, recruited from the Princess Margaret Cancer Center HNC clinics. In addition to the RC intervention, participants will be required to attend 3 research assessments (pre intervention, post intervention, and 1 month follow-up) that are a combination of face-to-face visits and telephone calls.
Quantitative data analysis will be exploratory and descriptive, and effect sizes will be calculated for all outcomes to help plan for a future, controlled trial. Means, standard deviations, and Cohen's d effect size will be calculated for normally distributed data. For non-normally distributed data, medians, ranges, and a nonparametric effect size r will be calculated. For qualitative analysis, all interviews will be audio recorded, transcribed verbatim, and analyzed using a two-phased, hybrid approach that is both deductive and inductive. Findings will be summarized and reported to the Advisory Panel, who will then make recommendations regarding any additional modifications to the RC. The research team will make final decisions about RC modifications and will finalize a version for future evaluation.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 35 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Pilot testing: single group pre-post design
Behavioral: Rehabilitation Consult (RC)
The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.
Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)
Cancer-specific self-report measure of quality of life, higher scores indicate higher self-reported quality of life. Scores can range from 0 to 148. Changes in overall score as well as subsets will be evaluated for evidence of impact of intervention.
Time frame: A) 1 week post-intervention, B) 1-2 months post intervention
Change in Medical Outcome Short Form (36) Health Survey - (SF-36)
Self-report quality of life questionnaire. Higher scores indicate a higher self-reported quality of life. The Physical Composite Score (PCS) and the Mental Composite Score (MCS) are reported. Scores range from 0 to 100 for each individual item on the scale. These scores are then converted into composite totals based on the scoring system provided with the outcome measure.
Time frame: A) 1 week post-intervention, B) 1-2 months post intervention
Change in Goal Performance, Satisfaction, and Self-efficacy
Participants completed the Brief Rehabilitation Assessment for Survivors Of Head And Neck Cancer (BRASH), a self report tool where participants rate their current performance, satisfaction with self-selected rehab goals, and rate their confidence in their ability to achieve each goal. Higher scores indicate greater self-reported, performance, satisfaction, and self-efficacy. Scores for each of confidence, performance, and satisfaction can range from 0 to 100. Each category is then compared to itself and the change calculated by subtracting the earlier score from the latter.
Time frame: A) 1 week post-intervention, B) 1-2 months post intervention
| Milestone | Rehabilitation Consult (RC) |
|---|---|
| Started | 35 |
| Received intervention | 30 |
| Completed post-test assessment | 21 |
| Completed | 20 |
| Not completed | 15 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Medical withdrawal | 2 |
| Withdrew: Withdrawal by subject | 3 |
Cancer-specific self-report measure of quality of life, higher scores indicate higher self-reported quality of life. Scores can range from 0 to 148. Changes in overall score as well as subsets will be evaluated for evidence of impact of intervention.
| score on a scale | Rehabilitation Consult (RC) |
|---|---|
| Mean difference (post - pre) | 3.1 ± 11.6 |
| Mean difference (follow-up - pre) | 5.3 ± 12.3 |
Self-report quality of life questionnaire. Higher scores indicate a higher self-reported quality of life. The Physical Composite Score (PCS) and the Mental Composite Score (MCS) are reported. Scores range from 0 to 100 for each individual item on the scale. These scores are then converted into composite totals based on the scoring system provided with the outcome measure.
| score on a scale | Rehabilitation Consult (RC) |
|---|---|
| PCS - Mean difference (post - pre) | 3.5 ± 7.6 |
| PCS - Mean Difference (follow-up - pre) | 6.7 ± 8.0 |
| MCS - Mean difference (post - pre) | 4.3 ± 9.5 |
| MCS - Mean Difference (follow-up - pre) | 2.8 ± 7.7 |
Participants completed the Brief Rehabilitation Assessment for Survivors Of Head And Neck Cancer (BRASH), a self report tool where participants rate their current performance, satisfaction with self-selected rehab goals, and rate their confidence in their ability to achieve each goal. Higher scores indicate greater self-reported, performance, satisfaction, and self-efficacy. Scores for each of confidence, performance, and satisfaction can range from 0 to 100. Each category is then compared to itself and the change calculated by subtracting the earlier score from the latter.
| score on a scale | Rehabilitation Consult (RC) |
|---|---|
| Performance (post - pre) | 16.6 ± 32.3 |
| Performance (follow-up - pre) | 37.3 ± 31.2 |
| Satisfaction (post - pre) | 26.9 ± 35.4 |
| Satisfaction (follow-up- pre) | 39.2 ± 32.6 |
| Self-efficacy (post - pre) | 18.4 ± 27.1 |
| Self-efficacy (follow-up- pre) | 17.1 ± 35.8 |
Collected over Adverse event data were collected during the 15 months when study participants were enrolled.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rehabilitation Consult (RC) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Rehabilitation Consult (RC) |
|---|---|
| Mean | 59.8 ± 13 |
| Sex: Female, Male(Participants) | Rehabilitation Consult (RC) |
|---|---|
| Female | 7 |
| Male | 28 |
| Race and Ethnicity Not Collected(Participants) | Rehabilitation Consult (RC) |
|---|
| Weeks post-treatment(weeks) | Rehabilitation Consult (RC) |
|---|---|
| Mean | 38.2 ± 22 |
| Had rehab goals(Participants) | Rehabilitation Consult (RC) |
|---|---|
| Count of participants | 23 |
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Sunnybrook Health Sciences Centre