Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Quality of Life

Patients with high risk cutaneous squamous cell carcinoma of the head-neck area receiving regular, multidisciplinary care.

Patients receiving regular care. In addition, validated questionnaires are administered at two measurement points:

1. after the multidisciplinary consultation, a baseline questionnaire\*, the decision conflict scale and the EQ-5D-5L questionnaire are administered by phone.
2. 1 month after completion of the treatment program (care pathway) the EQ-5D-5L, the BaSQoL and the EORTC IN-PATSAT32 questionnaires will be administered by phone.

Completing the questionnaires takes about 30 minutes each time.

\*Baseline questionnaire: gender, age, marital status, education level, World Health Organization (WHO) performance status, presence of informal care, stage and treatment of cSCC, history of skin cancer, presence of current other skin cancer, and average travel time to hospital.

Regular care with additionally administration of questionnaires

Emmy Cruts, MD

S.F.K. Lubeek, MD, PhD

K Mosterd, MD, PhD

Patient reported outcomes in patients with high-risk cutaneous squamous cell carcinoma in the head-neck region are an important part of the complex care for these patients. Health-related quality of life, decision conflicts in the choice of treatment and satisfaction with care have not yet been sufficiently studied in this patient group.

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.

Patient-reported outcomes and health related quality of life (HRQoL) are important outcomes in the care for high-risk cSCCs in the head-neck region (HNcSCCs). Previous research is limited regarding the impact of cSCCs on QoL in patients with high-risk HNcSCCs , as is research on decision conflicts in the choice of treatment. The PROFILES registry (Arts, 2019) investigated QoL and satisfaction with care in 215 patients with keratinocyte carcinomas in the head-neck region. However, the majority of the patients had basal cell carcinoma (81%); only 23 patients had cSCC. Besides, no distinction was made in high or low risk cSCC. Finally, quality of life and patient satisfaction questionnaires were not administered until at least one year after diagnosis.

Other studies of QoL in cSCC patients do not distinguish stage and/or location of the tumor, involve small study populations, or only use oncological questionnaires rather than disease-specific questionnaires.

In conclusion, there is little scientific research on health related quality of life, decision conflicts in the choice of treatment and satisfaction with care in specific patients with high-risk HNcSCCs.

Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region

Decisional Conflicts, Health-related Quality of Life and Satisfaction With Care in High-risk Cutaneous Squamous Cell Carcinoma in the Head-neck Region: Validated Questionnaires

Decisional conflicts expressed as mean total and domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and then multiplying by 25. The total score ranges from 0 to 100. A higher score correlates with a higher decisional conflict.

The 5 domain subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the (3 or 4) items, dividing by the number of items (3 or 4) and then multiplying by 25. The subscores range from 0 to 100 where a higher score correlates with a higher decisional conflict.

Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

Differences in decisional conflict outcome measures (primary outcome 1) between Maastricht University Medical Center+ and Radboud University Medical Center, expressed as mean total/domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and multiplying by 25 (total score range 0-100). A higher score correlates with a higher decisional conflict. The subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the items, dividing by the number of items and multiplying by 25. The subscores range from 0-100; a higher score correlates with a higher decisional conflict.

Differences in health-related quality of life outcome measures (primary outcome 2) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 3) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 4) between Maastricht University Medical Center+ and Radboud University Medical Center. HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Differences in satisfaction with care outcome measures (primary outcome 5) between Maastricht University Medical Center+ and Radboud University Medical Center. Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

The difference in HRQoL before and after treatment, expressed by mean total and domain scores on the EQ-5D-5L questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Maastricht University Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Rectal Neoplasms

Colonic Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Kathleen Castro, R.N.

Background:

-Coordinated cancer care provided by doctors, nurses, social workers, and other care providers is believed to improve patient and physician satisfaction and patient evaluation for enrollment in clinical trials. But no research has been done to show that this approach improves patient experiences and outcomes. Researchers want to study this model to better understand how it can improve cancer treatment and patient outcomes.

Objectives:

- To assess the relationship between coordinated care and cancer treatment processes and outcomes.

Eligibility:

- Individuals who are at least 18 years of age. Those who take part must have been diagnosed with colon, rectal, or non-small-cell lung cancer. They also must be receiving or have been treated at one of the 16 NCI Community Cancer Center program sites.

Design:

* Researchers will collect medical records data from participants.
* Participants will complete a questionnaire about 8 weeks after the end of all planned cancer treatment. They will be asked questions about their experience with coordinated cancer care. They will also be asked for any comments or concerns they had during and after treatment.
* No treatment or additional tests will be provided as part of this protocol.

There is little evidence regarding the effect of multidisciplinary care (MDC) on health outcomes across various cancer sites, including colon, rectal, and lung cancer. The current study addresses this gap by providing preliminary data regarding the relationship between MDC and selected processes and outcomes of care in NCCCP pilot sites. The long-term goal of this preliminary study is to generate effect sizes, establish feasibility, and build infrastructure to support the development of a larger more definitive study of MDC outcomes. The key aim of this pilot study is to determine the relationship between specific MDC assessment areas identified by a pre-existing MDC assessment tool (http://ncccp .cancer.gov /NCCCPMDC- Matrix- Tool. pdf ): case planning, physician engagement, coordination of care, infrastructure, financial, clinical trials and medical records, and each of the following outcomes \[0\] and processes \[P\]: 1) time to receipt of initial therapy\[P\]; 2) receipt of multi-modality therapy\[O\]; 3) evaluation for enrollment in a clinical trial\[P\]; 4) patient experience\[O\]; 5) adherence to NCCN treatment guidelines\[P\]; and 6) all-cause survival\[O\]. The study focuses on adult patients with an incident diagnosis of Stage III colon cancer, Stage II or III rectal cancer, or Stage III non-small cell lung cancer.

We will quantify the relationship between MDC, various care processes and outcomes across 16 participating NCCCP sites, testing the hypothesis that increasing levels of MDC identified by the MDC tool are associated with improvement in care quality and a survival advantage.

Significant progress has been achieved in the past year establishing the necessary

processes for conducting the research study and the deliverables associated with the study. In terms of process outcomes, we can report the following:

1. Institutional Review Board approval for the multidisciplinary care study at all 16

   sites;
2. The development of a Standard Operating Procedures manual for use by the 16 sites;
3. The development of a data collection form (Site Data Collection Tool) to be used for

   collecting information that is not available via the pre-existing web-based data

   collection system that is in place at the 16 sites;
4. The development of a data collection form to be used for documenting the facility s

   annual scores using the Multidisciplinary Care Assessment tool.
5. The development of a flowchart for use in operationalizing the measurement of

   NCCN guideline adherence for patients with Stage III non small cell lung cancer;
6. The development of a Frequently Asked Questions document to assist with

   addressing questions in real time;
7. Multiple training sessions/webinars have been held for the participating sites.
8. Monthly conference call with the research team and representatives from all

participating sites.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs	NCT01346280	Non-Small Cell ... Colon Cancer (S... Rectal Cancer (...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs	NCT01346280	Non-Small Cell ... Colon Cancer (S... Rectal Cancer (...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs	NCT01346280	Non-Small Cell ... Colon Cancer (S... Rectal Cancer (...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for multidisciplinary care