Quality of Life Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 248 |
Est. completion date | December 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients diagnosed with a T2 to T4 cutaneous squamous cell carcinoma located in the head-neck area (including patients with metastatic or recurrence disease) - requiring a multidisciplinary approach - assessed at the department of dermatology of Maastricht UMC+ or Radboud UMC OR discussed in the multidisciplinary consultation in Maastricht UMC+ or Radboud UMC - and for which treatment of the tumor (primary tumor or metastatic/recurrence) takes places in the Maastricht UMC+ of Radboud UMC - willing to participate voluntarily in the study Exclusion Criteria: - patients younger than 18 years - patients with inadequate understanding of the Dutch language - patients with cognitive impairment or otherwise unable to complete the questionnaires |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center + | Maastricht | Limburg |
Netherlands | Radboud UMC | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Abedini R, Nasimi M, Noormohammad Pour P, Moghtadaie A, Tohidinik HR. Quality of Life in Patients with Non-melanoma Skin Cancer: Implications for Healthcare Education Services and Supports. J Cancer Educ. 2019 Aug;34(4):755-759. doi: 10.1007/s13187-018-1368-y. — View Citation
Arts LPJ, Waalboer-Spuij R, de Roos KP, Thissen MRTM, Scheijmans LJ, Aarts MJ, Oerlemans S, Lybeert MLM, Louwman MWJ. Health-Related Quality of Life, Satisfaction with Care, and Cosmetic Results in Relation to Treatment among Patients with Keratinocyte Cancer in the Head and Neck Area: Results from the PROFILES Registry. Dermatology. 2020;236(2):133-142. doi: 10.1159/000502033. Epub 2019 Aug 21. — View Citation
Brantsch KD, Meisner C, Schonfisch B, Trilling B, Wehner-Caroli J, Rocken M, Breuninger H. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study. Lancet Oncol. 2008 Aug;9(8):713-20. doi: 10.1016/S1470-2045(08)70178-5. Epub 2008 Jul 9. — View Citation
Brougham ND, Dennett ER, Cameron R, Tan ST. The incidence of metastasis from cutaneous squamous cell carcinoma and the impact of its risk factors. J Surg Oncol. 2012 Dec;106(7):811-5. doi: 10.1002/jso.23155. Epub 2012 May 16. — View Citation
Chren MM, Sahay AP, Bertenthal DS, Sen S, Landefeld CS. Quality-of-life outcomes of treatments for cutaneous basal cell carcinoma and squamous cell carcinoma. J Invest Dermatol. 2007 Jun;127(6):1351-7. doi: 10.1038/sj.jid.5700740. Epub 2007 Feb 15. — View Citation
Kallini JR, Hamed N, Khachemoune A. Squamous cell carcinoma of the skin: epidemiology, classification, management, and novel trends. Int J Dermatol. 2015 Feb;54(2):130-40. doi: 10.1111/ijd.12553. Epub 2014 Nov 27. — View Citation
Mourouzis C, Boynton A, Grant J, Umar T, Wilson A, Macpheson D, Pratt C. Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience. J Craniomaxillofac Surg. 2009 Dec;37(8):443-7. doi: 10.1016/j.jcms.2009.07.007. Epub 2009 Aug 27. — View Citation
Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059. — View Citation
Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541-7. doi: 10.1001/jamadermatol.2013.2139. — View Citation
Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Concetta Fargnoli M, Forsea AM, Frenard C, Harwood CA, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NWJ, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 2. Treatment. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008. Epub 2020 Feb 26. — View Citation
Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26. — View Citation
van Egmond S, Wakkee M, Droger M, Bastiaens MT, van Rengen A, de Roos KP, Nijsten T, Lugtenberg M. Needs and preferences of patients regarding basal cell carcinoma and cutaneous squamous cell carcinoma care: a qualitative focus group study. Br J Dermatol. 2019 Jan;180(1):122-129. doi: 10.1111/bjd.16900. Epub 2018 Sep 23. — View Citation
Wang AY, Palme CE, Wang JT, Morgan GJ, Gebski V, Gilchrist J, Veness MJ. Quality of life assessment in patients treated for metastatic cutaneous squamous cell carcinoma of the head and neck. J Laryngol Otol. 2013 Jul;127 Suppl 2:S39-47. doi: 10.1017/S0022215113000303. Epub 2013 Mar 5. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decisional conflict | 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. |
At the start (before treatment) of the care pathway. | |
Primary | Health-related quality of life | 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). |
At the start (before treatment) of the care pathway. | |
Primary | Health-related quality of life | 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). |
At 1 month after completion of the care pathway. | |
Primary | Health-related quality of life | 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. |
At 1 month after completion of the care pathway. | |
Primary | Satisfaction with care | 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. |
Once during the care pathway: 1 month after completion of the care pathway. | |
Secondary | Difference in decisional conflict outcomes between centers | 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. |
At the start (before treatment) of the care pathway. | |
Secondary | Difference in health-related quality of life outcomes between centers | 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). |
At the start (before treatment) of the care pathway. | |
Secondary | Difference in health-related quality of life outcomes between centers | 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). |
At 1 month after completion of the care pathway. | |
Secondary | Difference in health-related quality of life outcomes between centers | 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. |
At 1 month after completion of the care pathway. | |
Secondary | Difference in satisfaction with care outcomes between centers | 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. |
At 1 month after completion of the care pathway. | |
Secondary | Change from baseline health-related quality of life after treatment | 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). |
Twice during the care pathway: at the start (before treatment) and 1 month after completion of the care pathway. |
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