Head and Neck Neoplasms
Conditions
Keywords
Rehabilitation, Head and neck cancer, Quality of life, self-efficacy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRehabilitation 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.
Sponsors
Princess Margaret Hospital, Canada
Toronto General Hospital
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.
Exclusion criteria
* Lack of English fluency, * Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and * Known active cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N) | A) 1 week post-intervention, B) 1-2 months post intervention | 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. |
| Change in Medical Outcome Short Form (36) Health Survey - (SF-36) | A) 1 week post-intervention, B) 1-2 months post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Goal Performance, Satisfaction, and Self-efficacy | A) 1 week post-intervention, B) 1-2 months post intervention | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rehabilitation Consult (RC) Pilot testing: single group pre-post design
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. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Medical withdrawal | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Rehabilitation Consult (RC) | — |
|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 13 | — |
| Had rehab goals | 23 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| Weeks post-treatment | 38.2 weeks STANDARD_DEVIATION 22 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rehabilitation Consult (RC) | Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N) | Mean difference (post - pre) | 3.1 score on a scale | Standard Deviation 11.6 |
| Rehabilitation Consult (RC) | Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N) | Mean difference (follow-up - pre) | 5.3 score on a scale | Standard Deviation 12.3 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rehabilitation Consult (RC) | Change in Medical Outcome Short Form (36) Health Survey - (SF-36) | MCS - Mean Difference (follow-up - pre) | 2.8 score on a scale | Standard Deviation 7.7 |
| Rehabilitation Consult (RC) | Change in Medical Outcome Short Form (36) Health Survey - (SF-36) | PCS - Mean difference (post - pre) | 3.5 score on a scale | Standard Deviation 7.6 |
| Rehabilitation Consult (RC) | Change in Medical Outcome Short Form (36) Health Survey - (SF-36) | PCS - Mean Difference (follow-up - pre) | 6.7 score on a scale | Standard Deviation 8 |
| Rehabilitation Consult (RC) | Change in Medical Outcome Short Form (36) Health Survey - (SF-36) | MCS - Mean difference (post - pre) | 4.3 score on a scale | Standard Deviation 9.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Performance (post - pre) | 16.6 score on a scale | Standard Deviation 32.3 |
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Performance (follow-up - pre) | 37.3 score on a scale | Standard Deviation 31.2 |
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Satisfaction (post - pre) | 26.9 score on a scale | Standard Deviation 35.4 |
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Satisfaction (follow-up- pre) | 39.2 score on a scale | Standard Deviation 32.6 |
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Self-efficacy (post - pre) | 18.4 score on a scale | Standard Deviation 27.1 |
| Rehabilitation Consult (RC) | Change in Goal Performance, Satisfaction, and Self-efficacy | Self-efficacy (follow-up- pre) | 17.1 score on a scale | Standard Deviation 35.8 |