SurvivorshipSHARENCT03993561
Treatment Summary and Survivorship Care Plans (TSSP)
A study testing Treatment summary and survivorship care plan in people with Survivorship and Head and Neck Cancer, run by Western University, Canada at 1 site in Canada.
Trial summary
The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by piloting the TSSPs on patients with HNC. Hypothesis: HNC patients who receive the intervention of the TSSP will have an increased rate of implementation of recommendations for their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship, Head and Neck Cancer
- What is being tested?
- Treatment summary and survivorship care plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- willing to provide informed consent
- diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx)
- last definitive treatment (surgery, chemotherapy, radiotherapy) at least 1 month but no greater than 3 months from enrollment
- English speaking
Who cannot join
- Second concurrent non-cutaneous malignancy
- metastatic disease
- clinically apparent cognitive impairment
- unable or unwilling to complete questionnaires
- suspected residual disease after treatment completion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survivorship After Head And Neck Cancer: Validation of Treatment Summary and Survivorship Care Plans
The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by piloting the TSSPs on patients with HNC.
Hypothesis: HNC patients who receive the intervention of the TSSP will have an increased rate of implementation of recommendations for their needs, greater adherence with follow-up schedules, improved quality of life and improved satisfaction with post-treatment care.
Read more
Aim 1 (Validation of TSSP): To validate a treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of HNC patients based on the best available evidence.
Approach: In the first phase of the project the investigators will pilot the London Heath Sciences Centre TSSP with head and neck cancer survivors and then have the TSSP extensively reviewed and modified by our multidisciplinary head and neck oncology treatment team.
Aim 2 (Evaluation of TSSP): To evaluate the implementation of a TSSP in survivors of head and neck cancer compared to usual treatment in a randomized fashion to determine whether TSSPs result in improved implementation of recommendations for HNC survivors and improved quality of life and satisfaction.
Approach: In the second phase of the project the investigators will conduct a randomized controlled trial to compare patient reported outcomes in HNC patients who have received the TSSP to patients who have not received the TSSP.
Read the detailed description
Validation of TSSP: The investigators have performed an extensive literature review to create a comprehensive draft TSSP specifically tailored for HNC patients. The investigators will pilot this study among 20 head and neck cancer survivors. Once the investigators have the feedback from the pilot patients, the investigators will conduct a focus group with the members of our head and neck multidisciplinary group to gain input on the TSSP.
Evaluation of TSSP: The investigators will recruit head and neck cancer survivors with curable stage I-IVA head and neck mucosal cancer at a tertiary level cancer center in Ontario. Patients will receive a survivorship care plan (TSSPs) intervention. The intervention will consist of a survivorship care nurse or radiation therapist counseling session coupled with the provision of individualized TSSPs to patients and their health care providers. After a baseline telephone or in-person interview, eligible participants will be provide with the TSSP.
The primary outcome will be physician implementation of TSSP care recommendations over the course of 12 months, assessed by quarterly patient interviews. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures and patient satisfaction with care.
- Conditions
- Survivorship, Head and Neck Cancer
- Being tested
- Treatment summary and survivorship care plan
- Keywords
- treatment summary and survivorship care plan, intervention, head and neck cancer survivors
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment summary and survivorship care planOther
Individually tailored counselling session will be implemented within 1 month of treatment completion.
| Study group | Role | What they receive |
|---|---|---|
| TSSP Group | Experimental | A one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists will be provided Receives: Other: Treatment summary and survivorship care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician implementation of TSSP
Physician implementation of treatment summaries and survivorship care plans (TSSP) recommendations over the course of 12 months, assessed by quarterly patient interviews.
Measured: 12 months
Secondary outcomes (8)
Satisfaction with Care and Communication
8-item questionnaire measuring patient level of satisfaction with follow-up care since head and neck cancer treatment ended; 4 questions are ranked using a 6-point Likert scale (1 = Never and 6 = Always), 1 item uses a 5-point likert scale (1 = Definitely yes; 5 = Definitely not); 2 items use a scale of 0-10 (0 = not at all satisfied and 10 = very satisfied); and one item utilized a Yes or No response format. Total scores range from 5 to 50;
Measured: baseline and 12 months post-treatment
Patient Self-Efficacy (PEPPI)
Five item patient self-efficacy measured on a scale of 0 to 10 (0 = not confident at all, 10 = extremely confident); higher scores indicate better satisfaction with care; Total scores range from 0 to 50;
Measured: baseline and 12 months post-treatment
KATZ Comorbidity Scale
Patient rated comorbidity scale based on the Charlson Comborbidity index. Thirty-five item scale measures the presence or absence of different health conditions. Each item utilizes a Yes/No format; Yes' are given a point of 1 and No's are scored 0; Higher scores indicate the presence of a greater number of co-morbidities and lower scores; Total scores range from 0 to 35;
Measured: baseline and 12 months post-treatment
36-Item Short Form Survey Instrument (SF-36)
36 item scale to measure patient health and wellbeing from the patient perspective; Eight subscale scores are generated for the following domains: 1) physical functioning, 2) role-physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role-emotional, and 8) mental health; Item scales range from 3 to 6 point Likert scales and Yes/No response formats; items are recoded to a scale of 0 to 100; after recoding, averages for each subscale are calculated so that each subscale has a range of 0 to 100 (0 being poor functioning and 100 excellent functioning); higher subscale scores indicate better health.
Measured: baseline and 12 months post-treatment
Personal Health Questionnaire Depression Scale (PHQ-8)
Eight-item self-reported depression scale; each item is scored using a 4-point likert scale (0 = Not at all, 3 = Nearly every day); Total scores range from 0 to 24; A score of 10 or greater is considered major depression, 20 or more is severe depression;
Measured: baseline and 12 months post-treatment
Knowledge and Preparedness for Survivorship Scale (PLANS scale)
Sixteen- item knowledge of survivorship issues questionnaire; Items 1-11 use a 4-point scale (1 = Strongly disagree; 4 = Strongly agree) and addresses knowledge of survivorship issues; items 12 to 16 utilize a 10-point scale (1 = Not at all confident; 10 = Extremely Confident) and evaluate patient preparedness for survivorship; Subscale total scores for Knowledge of Survivorship Issues subcale range from 11 to 44 with higher scores indicating better knowledge of survivorship issues; The Preparedness for Survivorship (items 12-16) subscale score ranges from 5 to 50 with higher scores indicating greater level of confidence regarding preparedness for survivorship
Measured: baseline and 12 months post-treatment
Short-Form Patient Satisfaction Questionnaire (PSQ-18)
Eighteen-item patient satisfaction with care questionnaire using a 5-point Likert scale (1 = Strongly agree; 5 = Strongly disagree); Five subscale scores are generated by calculating averages of items that belong to that particular subscale: General Satisfaction, Technical Quality, Interpersonal Manner, Communication, Financial Aspects, Time Spent with Doctor, Accessibility and Convenience; Each subscale score ranges from 1 to 5 with higher scores reflecting greater level of satisfaction with care;
Measured: baseline and 12 months post-treatment
Social support survey
Nineteen-item scale measuring social, tangible and emotional support; Each item is ranked on a 5-point likert scale (1 = None of the time and 5 = All of the time); Higher scores indicate greater social support;
Measured: baseline and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Aug 2020
- Primary completion31 Mar 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, pilot trial at a single centre with 1 group of 20 adults. The study group will receive a one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle MacNeil, Western University, Canada
- Investigators
- Danielle MacNeil, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993561
- Sponsor's protocol ID
- 114194
- Acronym
- SHARE
- Status last verified
- Nov 2023
- First submitted
- 18 Jun 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship After Head And Neck Cancer: Validation of Treatment Summary and Survivorship Care Plans
- ClinicalTrials.gov ID
- NCT03993561
- Acronym / sponsor ID
- SHARE / 114194
- Conditions
- Survivorship, Head and Neck Cancer
- Keywords
- treatment summary and survivorship care plan, intervention, head and neck cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by piloting the TSSPs on patients with HNC.
Hypothesis: HNC patients who receive the intervention of the TSSP will have an increased rate of implementation of recommendations for their needs, greater adherence with follow-up schedules, improved quality of life and improved satisfaction with post-treatment care.
Aim 1 (Validation of TSSP): To validate a treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of HNC patients based on the best available evidence.
Approach: In the first phase of the project the investigators will pilot the London Heath Sciences Centre TSSP with head and neck cancer survivors and then have the TSSP extensively reviewed and modified by our multidisciplinary head and neck oncology treatment team.
Aim 2 (Evaluation of TSSP): To evaluate the implementation of a TSSP in survivors of head and neck cancer compared to usual treatment in a randomized fashion to determine whether TSSPs result in improved implementation of recommendations for HNC survivors and improved quality of life and satisfaction.
Approach: In the second phase of the project the investigators will conduct a randomized controlled trial to compare patient reported outcomes in HNC patients who have received the TSSP to patients who have not received the TSSP.
Detailed description
Validation of TSSP: The investigators have performed an extensive literature review to create a comprehensive draft TSSP specifically tailored for HNC patients. The investigators will pilot this study among 20 head and neck cancer survivors. Once the investigators have the feedback from the pilot patients, the investigators will conduct a focus group with the members of our head and neck multidisciplinary group to gain input on the TSSP.
Evaluation of TSSP: The investigators will recruit head and neck cancer survivors with curable stage I-IVA head and neck mucosal cancer at a tertiary level cancer center in Ontario. Patients will receive a survivorship care plan (TSSPs) intervention. The intervention will consist of a survivorship care nurse or radiation therapist counseling session coupled with the provision of individualized TSSPs to patients and their health care providers. After a baseline telephone or in-person interview, eligible participants will be provide with the TSSP.
The primary outcome will be physician implementation of TSSP care recommendations over the course of 12 months, assessed by quarterly patient interviews. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures and patient satisfaction with care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, pilot trial at a single centre with 1 group of 20 adults. The study group will receive a one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists.
| Arm | Type | Receives |
|---|---|---|
| TSSP Group | Experimental | Other: Treatment summary and survivorship care planA one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists will be provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- willing to provide informed consent
- diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx)
- last definitive treatment (surgery, chemotherapy, radiotherapy) at least 1 month but no greater than 3 months from enrollment
- English speaking
Key exclusion criteria (5 listed)
- Second concurrent non-cutaneous malignancy
- metastatic disease
- clinically apparent cognitive impairment
- unable or unwilling to complete questionnaires
- suspected residual disease after treatment completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment summary and survivorship care planIndividually tailored counselling session will be implemented within 1 month of treatment completion. | Other | TSSP Group |
Primary outcome
Physician implementation of TSSP
Time frame: 12 months
Physician implementation of treatment summaries and survivorship care plans (TSSP) recommendations over the course of 12 months, assessed by quarterly patient interviews.
8 secondary outcomes
Satisfaction with Care and Communication
Time frame: baseline and 12 months post-treatment
Patient Self-Efficacy (PEPPI)
Time frame: baseline and 12 months post-treatment
KATZ Comorbidity Scale
Time frame: baseline and 12 months post-treatment
36-Item Short Form Survey Instrument (SF-36)
Time frame: baseline and 12 months post-treatment
Personal Health Questionnaire Depression Scale (PHQ-8)
Time frame: baseline and 12 months post-treatment
Knowledge and Preparedness for Survivorship Scale (PLANS scale)
Time frame: baseline and 12 months post-treatment
Short-Form Patient Satisfaction Questionnaire (PSQ-18)
Time frame: baseline and 12 months post-treatment
Social support survey
Time frame: baseline and 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No. Data will be made available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle MacNeil, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment summary and survivorship care plan in people with Survivorship and Head and Neck Cancer, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician implementation of TSSP (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.