Trial Outcomes & Findings for Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer (NCT NCT02836769)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

A) 1 week post-intervention, B) 1-2 months post intervention

Results posted on

2021-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	35
Overall Study Received Intervention	30
Overall Study Completed Post-test Assessment	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	10
Overall Study Medical withdrawal	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rehabilitation Consult (RC) n=35 Participants 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.
Age, Continuous	59.8 years STANDARD_DEVIATION 13 • n=35 Participants
Sex: Female, Male Female	7 Participants n=35 Participants
Sex: Female, Male Male	28 Participants n=35 Participants
Weeks post-treatment	38.2 weeks STANDARD_DEVIATION 22 • n=35 Participants
Had rehab goals	23 Participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rehabilitation Consult (RC) n=30 Participants 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.
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rehabilitation Consult (RC) n=30 Participants 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.
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
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 8.0
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rehabilitation Consult (RC) n=30 Participants 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.
Change in Goal Performance, Satisfaction, and Self-efficacy Satisfaction (follow-up- pre)	39.2 score on a scale Standard Deviation 32.6
Change in Goal Performance, Satisfaction, and Self-efficacy Performance (post - pre)	16.6 score on a scale Standard Deviation 32.3
Change in Goal Performance, Satisfaction, and Self-efficacy Performance (follow-up - pre)	37.3 score on a scale Standard Deviation 31.2
Change in Goal Performance, Satisfaction, and Self-efficacy Satisfaction (post - pre)	26.9 score on a scale Standard Deviation 35.4
Change in Goal Performance, Satisfaction, and Self-efficacy Self-efficacy (post - pre)	18.4 score on a scale Standard Deviation 27.1
Change in Goal Performance, Satisfaction, and Self-efficacy Self-efficacy (follow-up- pre)	17.1 score on a scale Standard Deviation 35.8

Adverse Events

Rehabilitation Consult (RC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sara McEwen

Sunnybrook Research Institute

Phone: 416-226-6780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place