The effect of comprehensive counseling by a nurse specialist on depressive symptoms and quality of life: A prospective randomized study in patients with head and neck cancer.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23760

Enrollment

154

Registered

2005-09-07

Start date

2003-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Comprehensive counseling will be given by a nurse specialist, especially trained for this purpose. The patient will be referred for a short contact before the start of surgery or before the start of

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, receiving treatment with surgery and/or radiotherapy with curative intent; 2. No previous or synchronous malignancies, with the exception of: adequately treated squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix synchronous second squamous cell carcinoma of oral cavity, pharynx or larynx which can also be treated with curative intent; 3. Ability to complete the questionnaire and expected cooperation of the patient, as reflected by a completed baseline questionnaire.

Exclusion criteria

Exclusion criteria: No further exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Depression will be measured with the Center for Epidemiological Studies-Depression Scale (CES-D) (Radloff 1977, Bouma 1988, Hanewald 1992). The CES-D consists of 20 items with a 4 point Likert scale, resulting in a total score ranging from 0 to 60 (Bouma 1988). A high score reflects a high level of depression. A cut-off point of 16 can be used, patients with a score of 16 or more being classified as being a possible case of depression. This questionnaire has been developed for research in the general, non-psychiatric population, it contains 20 items and has been used in Duch cancer research (Komproe 1995, de Graeff 2000, de Leeuw 2000)	—

Measure

Time frame

Depression will be measured with the Center for Epidemiological Studies-Depression Scale (CES-D) (Radloff 1977, Bouma 1988, Hanewald 1992). The CES-D consists of 20 items with a 4 point Likert scale, resulting in a total score ranging from 0 to 60 (Bouma 1988). A high score reflects a high level of depression. A cut-off point of 16 can be used, patients with a score of 16 or more being classified as being a possible case of depression. This questionnaire has been developed for research in the general, non-psychiatric population, it contains 20 items and has been used in Duch cancer research (Komproe 1995, de Graeff 2000, de Leeuw 2000)

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Secondary

Measure	Time frame
1. Quality of Life with the EORTC Core Questionnaire (QLQ-C30, version 3.0)(Aaronson 1993) and the EORTC Head and Neck Module (QLQ-H&N35) (Bjordal 1999, Bjordal 2000). The QLQ-C30 contains five functional scales, three symptom scales, a global QoL scale and six sin-gle-items. It has been tested in an international study in which Dutch patients participated, contains 33 items concerning global quality of life, functional capacity, physical and psychological symptoms, and daily activities; 2. The QLQ-H&N35 measures tumour-specific and treatment related symptoms. This questionnaire has also been tested in an international study in which Dutch patients participated and contains seven symptom scales (pain, swallowing, senses (taste/smell), speech, social eating, social con-tacts, and sexuality) and six single items (teeth problems, trismus, dry mouth, sticky saliva, cough, and feeling ill); 3. Concern with recurrence of cancer will be measured with the Worry of Cancer Scale (Easterling, 1989). This questionnaire contains 5 items measuring the fear of cancer recurrence; 4. Uncertainty is measured with the Uncertainty in Illness Scale (Michel, 1981), containing 30 items measuring ambiguity and unpredictability.	—

Measure

Time frame

1. Quality of Life with the EORTC Core Questionnaire (QLQ-C30, version 3.0)(Aaronson 1993) and the EORTC Head and Neck Module (QLQ-H&N35) (Bjordal 1999, Bjordal 2000). The QLQ-C30 contains five functional scales, three symptom scales, a global QoL scale and six sin-gle-items. It has been tested in an international study in which Dutch patients participated, contains 33 items concerning global quality of life, functional capacity, physical and psychological symptoms, and daily activities; 2. The QLQ-H&N35 measures tumour-specific and treatment related symptoms. This questionnaire has also been tested in an international study in which Dutch patients participated and contains seven symptom scales (pain, swallowing, senses (taste/smell), speech, social eating, social con-tacts, and sexuality) and six single items (teeth problems, trismus, dry mouth, sticky saliva, cough, and feeling ill); 3. Concern with recurrence of cancer will be measured with the Worry of Cancer Scale (Easterling, 1989). This questionnaire contains 5 items measuring the fear of cancer recurrence; 4. Uncertainty is measured with the Uncertainty in Illness Scale (Michel, 1981), containing 30 items measuring ambiguity and unpredictability.

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Contacts

Public ContactJ.R.J. Leeuw, de

University Medical Center Utrecht (UMCU), Department of Nursing Science, P.O. Box 80036

j.r.j.deleeuw@umcutrecht.nl+31 (0)30 2538879

Outcome results