Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001447244 Date of Approval: 28/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of targeted psychotherapy on quality of life outcomes in palliative care patients
Official scientific title Effect of targeted psychotherapy on quality of life outcomes in palliative care patients- A parallel design randomised clinical trial
Brief summary describing the background and objectives of the trial key in provision of good clinical care to palliative patients is addressing psycho social and spiritual welfare in addition to physical symptoms.Dignity therapy aims to provide holistic treatment thus improving quality of life in these patients. Primary objective: To assess quality of life outcomes in those receiving dignity therapy + usual care compared to those receiving usual care only.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,quality of life in palliative care
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2016
Actual trial start date 11/07/2016
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 28/10/2016
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 144
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation,computer generated 1:1ratio Sealed opaque envelopes Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dignity therapy stat at first contact Dignity therapy 72
Control Group Usual care stat at first contact and thereafter Palliative care 72 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with advanced cancers(stage 3 0r 4) Good cognitive status i.e MMSE >20 and able to communicate effectively Age above 18years Can communicate in English or Kiswahili Acute illness easily reversible Age below 18 years 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No Research and Ethics committee, Agakhan University Hospital
Ethics Committee Address
Street address City Postal code Country
30270 Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 02/05/2016 Research Ethics committee, AKUHN
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvemnt in quality of life parameters using a QOL tool 1 week to 1 month from initial contact(timeline is set as per previous studies)
Primary Outcome improvemnt in quality of life parameters( composite score) using a QOL tool 1 week to 1 month from initial contact(timeline is set as per previous studies)
Secondary Outcome individual scores of QOL tool 1 week to 1 month (as per previous studies).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agakhan University Hospital 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Agakhan University Hospital 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Agakhan University Hospital 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr. John Weru 30270 Nairobi 00100 Kenya
Dr. Peter Waweru 30270 Nairobi 00100 Kenya
Professor Rodney Adam 30270 Nairobi 00100 Kenya
Dr. Alice Musibi 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Miriam Gatehi miriam.gatehia@aku.edu 0722441891 39544
City Postal code Country Position/Affiliation
Nairobi 00623 Kenya Resident Internal Medicine, Agakhan University Hospital
Role Name Email Phone Street address
Public Enquiries Miriam Gatehi miriam.gatehia@aku.edu 0722441891 39544
City Postal code Country Position/Affiliation
Nairobi 00623 Kenya Resident Internal Medicine, Agakhan University Hospital
Role Name Email Phone Street address
Scientific Enquiries Rodney Adam rodney.adam@aku.edu 0739127531 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor in Pathology, Agakhan University Hospital. Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information