Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

NCT02836769 | Completed Results

• 1 other identifier: 246-2013
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms

Keywords

Rehabilitation; Head and neck cancer; Quality of life; self-efficacy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (1)

• Change in Goal Performance, Satisfaction, and Self-efficacy

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

Study Arms (1)

Rehabilitation Consult (RC)

EXPERIMENTAL

Pilot testing: single group pre-post design

Behavioral: Rehabilitation Consult (RC)

Interventions

Rehabilitation Consult (RC) BEHAVIORAL

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.

Rehabilitation Consult (RC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.

You may not qualify if:

• Lack of English fluency,
• Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and
• Known active cancer.

Sponsors & Collaborators

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

Study Sites (2)

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Limitations and 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.

Results Point of Contact

• Title: Dr. Sara McEwen
• Organization: Sunnybrook Research Institute

sara.mcewen@sunnybrook.ca

416-226-6780

Study Officials

• Sara McEwen, PhD

  Sunnybrook Research Institute, St. John's Rehab Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: July 19, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)