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.: PACTR202007829295775 Date of Approval: 10/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the feasibility of a socio-spiritual intervention to improve quality of life of adults living with cancer and their family caregivers: A randomised controlled trial.
Official scientific title Evaluating the feasibility of a socio-spiritual intervention to improve quality of life of adults living with cancer and their family caregivers: A randomised controlled trial.
Brief summary describing the background and objectives of the trial The burden of cancer in Africa has long been one of the lowest in the world, but is steadily increasing. This reflects the World Health Organization's predictions that there will be a significant increase in the incidence and mortality of cancer in low and middle-income countries. Despite advances in cancer management, most African societies remain poorly prepared to cope with endemic cancer. For instance, Nigeria, the largest country in Africa with a population of about 200 million, has limited capacity to treat cancer due to inadequate/inaccessible medical facilities, corruption, lack of infrastructure and qualified personnel. Though, a variety of psychosocial interventions have been used to assist adults living with cancer and family caregivers in managing the effects of cancer and caregiving on QoL. These were mainly investigated in high-income countries, with no published studies coming from Africa, or Nigeria in particular The primary aim is to test the feasibility indicators (i.e. eligibility rate, recruitment rate, attrition rate, adherence, number of adverse events, ratings of burden and acceptability) of a psychosocial intervention to be delivered in the first three months of diagnosis that addresses the psychosocial needs of adults living with cancer and their family caregivers. The secondary aim is to evaluate if the intervention was useful in improving the QoL of adults living with cancer and their family caregivers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Socio-spiritual intervention
Anticipated trial start date 05/10/2020
Actual trial start date 21/12/2020
Anticipated date of last follow up 26/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 152
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group a sociospiritual intervention Four weekly face-to-face sessions lasting 120 minutes 120 minutes A 4-week plan including face-to-face training, video coaching sessions and counselling will be implemented for adults living with cancer and their family caregivers in the intervention group. The intervention will be delivered by a clinical nurse researcher. It consists of four components, two-hour sessions dealing with different behavioural and social aspects that influence QoL. These factors encompass adult with cancer-family caregiver dyadic (i) family/social support, (ii) spiritual support, (iii) interpersonal communication and relationships and (iv) cancer health literacy (see Table 1). The intervention will be delivered to patient-caregiver pairs (dyads) in a group format of five to seven dyads. Two groups will be running on the same schedule but on different days of the week. The total program for all participants will be delivered over four months. Group sessions will provide opportunities to express feelings and discuss issues of shared concern. For example, discussions will enable participants to gain an understanding of their experiences and how these may have changed their view of life, guiding them to adopt an optimistic cognitive framework for coping with stress and finding benefits in their situation. A room at the hospital will be used for group sessions. Researchers will contact participants by telephone in advance as a reminder about the forthcoming session and encourage attendance as much as possible. This approach aims to be supportive and identify any difficulties participants may be experiencing (such as transport; appointment clashes). 76
Control Group Usual care The control group of the study will receive the usual care (standard medical treatment and other appointments) Nil The control group of the study will receive the usual care (standard medical treatment and other appointments) 76 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria are adult (age 18 or older) living with cancer, diagnosis made within 3 months, family caregiver of an adult living with cancer, literate to at least junior secondary school level (Grade 9) in order to complete a self-administered questionnaire. Family caregivers will be excluded if, at the time of the study, are also receiving treatment for cancer, or a condition which increases their physical and/or psychological vulnerability or patients in advanced stage of cancer. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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
Yes 26/05/2020 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Zaria 810105 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2020 Griffith University Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
68 University Dr, Meadowbrook QLD Logan city 4131 Australia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility of the intervention 1 and 2
Secondary Outcome Social support, Spiritual support, Cancer health literacy, and Quality of life 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncolgy clinic Ahmadu Bello University Teaching Hospital Ahmadu Bello University Teaching Hospital, Shika Zaria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Griffith University Queensland 68 University Dr, Meadowbrook Brisbane 4131 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Griffith University Logan Campus Brisbane Australia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elisabeth Coyne e.coyne@griffith.edu.au +61403021699 School of Nursing and Midwifery, Logan Campus, Griffith University
City Postal code Country Position/Affiliation
Brisbane Australia Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Debra Creedy d.creedy@griffith.edu.au +61407555105 School of Nursing and Midwifery, Griffith University, Logan Campus, Queensland
City Postal code Country Position/Affiliation
Brisbane Australia Professor
Role Name Email Phone Street address
Public Enquiries Israel Gabriel israel.gabriel@griffithuni.edu.au +61422864013 Griffith University, Logan Campus, Queensland
City Postal code Country Position/Affiliation
Brisbane Australia PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this study will be made available by corresponding author after de-identification upon reasonable request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD and any additional supporting information will become available starting immediately following publication. No end date Free text
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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