A thematic analysis of semi-structured interviews using a phenomenological approach into palliative care patients experiences of change in fatigue following treatment with methylphenidate– an exploratory study - Patients Experiences of change in Fatigue during treatment with methylphenidate

• Conditions: Patients with cancer in palliative stage of their illness. Suffering from fatigue with or without decreased concentration, depression or drowsiness, who feel their fatigue is severe enough to decrease their quality of life.

• Registration Number: EUCTR2004-000502-40-GB
• Lead Sponsor: Southampton University Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-05
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Any patient, known to have cancer, entering the Countess Mountbatten Service who describes drowsiness, fatigue, tiredness, lethargy, decreased concentration or other similar symptom that is interfering with their daily living or quality of life.
•With or without symptoms and signs of clinical depression.
•Must be capable of understanding the patient leaflet though this may be read for them.
•Must be willing to give written consent (unless physical disability prevents this at which time audio recorded verbal consent will be accepted). Audio-recorded verbal consent will be stored as with the rest of the study audio recordings for 15 years on Digital Video Disc.
•Aged 18 years or over
•Patient aware of diagnosis
•Patient well enough to undertake study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

As identified by the manufacturers data sheet;
•A history of on-going hypertension requiring medical treatment.
•A previous history of agitated psychosis whether alone or as part of delirium, depression or other psychiatric illness.
•A previous history of anxiety attacks or anxiety disorder.

Study considerations;
•Patients GP unwilling to consider continuation of treatment following trial if the patient wishes it.
•Involvement in another concurrent research trial.
•Use of alternative remedies with unknown side effect profiles and possible interactions with the trial drug.
•Patient imminently dying.
•No telephone available at their place of residence, as this will make patient follow up much more difficult and may introduce delays in reporting of side effects.
•Significant deafness, speech impediment or other disability leading to recording of interviews being impossible.
•Patient not able to converse in English.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified