HNC-RC: Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT02836769
• Collaborator: Princess Margaret Hospital, Canada (Other), Toronto General Hospital (Other), University Health Network, Toronto (Other)
• Enrollment: 35
• Locations: 2
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms	Behavioral: Rehabilitation Consult (RC)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development and Pilot Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Rehabilitation Consult (RC) 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
2	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre
• Princess Margaret Hospital, Canada
• Toronto General Hospital
• University Health Network, Toronto

Investigators

• Principal Investigator: Sara McEwen, PhD, Sunnybrook Research Institute, St. John's Rehab Program

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 11, 2016

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT02836769
• Other Study ID Numbers: 246-2013
• First Posted: Jul 19, 2016
• Last Update Posted: Sep 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sunnybrook Health Sciences Centre: Rehabilitation; Head and neck cancer; Quality of life; self-efficacy
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

Participant Flow

Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	35
Received Intervention	30
Completed Post-test Assessment	21
COMPLETED	20
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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 Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.8 (13)
Sex: Female, Male (Count of Participants)
Female	7 20%
Male	28 80%
Race and Ethnicity Not Collected (Count of Participants)
Weeks post-treatment (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	38.2 (22)
Had rehab goals (Count of Participants)
Count of Participants [Participants]	23 65.7%

Outcome Measures

1. Primary Outcome

Title	Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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.
Measure Participants	30
Mean difference (post - pre)	3.1 (11.6)
Mean difference (follow-up - pre)	5.3 (12.3)

2. Primary Outcome

Title	Change in Medical Outcome Short Form (36) Health Survey - (SF-36)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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.
Measure Participants	30
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)

3. Secondary Outcome

Title	Change in Goal Performance, Satisfaction, and Self-efficacy
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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.
Measure Participants	30
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)

Adverse Events

Time Frame	Adverse event data were collected during the 15 months when study participants were enrolled.
Adverse Event Reporting Description	The risk of serious adverse events, mortality, and other adverse events was low because the study tested a behavioural intervention. Definitions of adverse events are in alignment with the Clinicaltrials.gov definitions.
Arm/Group Title	Rehabilitation Consult (RC)
Arm/Group Description	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.
All Cause Mortality
	Rehabilitation Consult (RC)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Rehabilitation Consult (RC)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Rehabilitation Consult (RC)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

This study did not include a control group and it is not known whether the improvements are due to the intervention, time, or other factors. Results from a single hospital may not be generalizable to other head and neck populations.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.