Study design
A single-centre, two-arm RCT will test the feasibility and evaluates efficacy of the socio-spiritual intervention for adults living with cancer and their family caregivers. Eligible participants will be randomly assigned to either the intervention or control group at a 1:1 ratio.
This study protocol was developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement guidelines for designing and reporting RCTs (24); the SPIRIT checklist (additional file 2) and the schedule of procedures can be seen in Table 1.
This trial was registered at the Pan African Clinical Trial Registry (www.pactr.org) (PACTR202007829295775) on 15 June 2020.
Setting
The study will be conducted at the Oncology Unit of a large, publicly funded tertiary referral hospital in Nigeria. Patients are referred to the hospital from all over the Northern region of Nigeria.
Eligibility criteria
Adults living with cancer and their family caregivers will be recruited. Eligibility criteria are adults (aged 18 or older) living with cancer (or adult family caregiver), receiving their first diagnosis within the last three months, literate to at least junior secondary school level (Grade 9) to complete self-administered questionnaires, and willingness to participate in a 2-hour program each week for four weeks. Exclusion criteria include patients with advanced cancer, or family caregivers who at the time of the study were also receiving treatment for cancer, or a condition that increased their physical and/or psychological vulnerability; unable to understand and speak English, and not able to complete self-reported surveys.
Intervention
The Behaviour Change Wheel framework was used to develop an evidence-based socio-spiritual intervention (referred to here as the “Zaman Lafiya Programme,” a local vernacular name that means “Living Well”). Guided by the findings of a local needs survey, the intervention was designed to meet the needs of adult Nigerians living with cancer and their family caregivers to improve family/social support, spiritual support, and information/health literacy (20). The spiritual framework informed program content and processes to be congruent with the Nigerian culture. It was based on the assumption that lifestyles, social support, psychodynamics of ritual, psychodynamics of cognitive schemata, and supernatural effects influence QoL (see Figure 1). The intervention consists of four, two-hour sessions addressing different behavioural and social aspects that influence QoL. These factors encompass adult with cancer-family caregiver dyadic (i) understanding cancer journey – need for family/social support and spirituality, (ii) sharing the journey – communication and building trusting relationships, (iii) finding the right support – family/social support and spiritual support and (iv) staying strong to overcome adversity – understanding strengths and resources of the family by building spiritual support (see Table 2).
The intervention is a nurse-led, face-to-face program that includes activities and resources (video and paper) to facilitate intervention delivery. 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. The intervention will be delivered to adults with cancer-caregiver pairs (dyads) in a group format of five to seven dyads. Each group will run once a week for 4 weeks. Delivery of the program for all participants will be completed within four months. 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). All participants in the study will receive a nominal amount ($10) for attendance which can be used to purchase a meal or pay for public transport.
Control group
Participants in the control arm will receive routine medical and nursing care which will also be provided to participants in the intervention arm. For ethical reasons, and if desired; participants assigned to the control group will be offered a printed copy of intervention resources and a one-day workshop after data collection is complete.
Outcomes
The primary and secondary outcomes are presented in Table 3. The study will follow the guidelines used by Leon., Davis. (25) to demonstrate feasibility of a study according to rates of eligibility (per cent screened for participants who were eligible), acceptance (proportion of those who screen eligible who enrol), retention (attrition and number of sessions completed by study arm), assessment process (proportion of planned assessments that are completed by participants), and intervention fidelity (percentage and similarity of session content covered across sessions by study facilitators).
Primary outcome measure – To test the feasibility (rates of eligibility, acceptance, retention, assessment process, and fidelity) of the intervention, research assistants will score:
Recruitment and acceptance rates at baseline (T1).
Assessment process and fidelity will be throughout the trial.
Retention rate at T2.
Fidelity will be rated using a structured adherence checklist form to evaluate sessions in the study arm for a subset (50%) session. The intervention fidelity scores range from 0 to 100, depending on the number of topics discussed during the session.
Feasibility of the study will be demonstrated if 80% of participants complete all sessions and assessments. A 60% recruitment rate will be considered acceptable. The retention and assessment process benchmarks are 80% and covering 80 to 100% of topics would be regarded as high fidelity (26).
Secondary outcome measures – Efficacy of the intervention will include measures of the outcome variables (spiritual needs, family/social needs, information needs, health literacy, and QoL), repeated measurements will be conducted pre and post intervention. The surveys will be completed by participants in both the intervention and control groups.
Participant’s timeline
For everyone in the intervention group, surveys will be completed at two-time points: baseline (T1), and immediately following completion of socio-spiritual intervention (four weeks, T2) (Figure 2) to determine whether the intervention has an immediate impact on the study outcomes. Participants in the control group will complete surveys within the same timeframe (baseline; + 4 weeks).
Sample size
A power analysis was performed to determine the sample size required to evaluate the efficacy of the intervention. Based on a previous related intervention study (27), a sample of 76 participants (38) dyads in each arm will provide 85% power for repeated-measures analysis of variance (time 1 vs time 2) with a moderate effect size and probability of 0.05. A final sample of 152 participants (adults with cancer and family caregivers) will be needed.
Recruitment and consent
Participants will be recruited at the oncology and outpatient clinics. All staff working in the oncology unit will be informed about the study by the research team. As shown in Figure 2, recruitment is a three-step process involving the following:
Initially identifying potential participants against inclusion and exclusion criteria: Nurses will identify and refer all potential participants who meet the inclusion criteria to research assistants who will be present at the clinic.
Approaching and informing potential participants of the study: The researcher will provide written and verbal information to adults living with cancer and family caregivers about the purpose and processes of the study. Patients who attend the clinic without a family caregiver but are interested in participating will be encouraged to discuss the study with their family, decide on a nominee, and notify the research assistant.
Consent: Those interested in the study will be given research information sheet, and then sign an informed consent form, which will be collected by the researcher.
Randomisation and blinding
Participants who meet the study criteria and give informed consent to participate in the study will be randomly assigned either to the intervention or control group (Figure 2). Computer-generated block randomisation will be performed to ensure equal (1:1) allocation. An independent researcher who is not involved in the study will carry out the allocation procedure. As a result, the research assistants who will be participating in group facilitation and participants will be blinded to the allocation of participants (allocation concealment). The allocation outcome will be communicated to research assistants by phone who will inform participants of their allocation and subsequent study procedure.
Withdrawal criteria
Participants are not under any obligation to participate in this trial. Therefore, they are also entirely free to discontinue participation at any time without penalty, or to decline to answer specific questions. The decision to participate in the study has no impact on the treatment participants receive from the Hospital.
Data collection
For all participants, socio-demographic data (age, gender, ethnicity, education, marital status, religion, economic status, relationship to the patient, duration of caregiving), clinical information (including cancer type, and stage of cancer), primary outcome (recruitment rate and acceptance, retention rate, and assessment process), and secondary outcomes (social/family needs, spiritual needs, information needs, health literacy, and QoL) will be measured. Well-validated measures will be used (see Table 3).
Independent variables
Social/family needs – The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief instrument designed to measure perceptions of support from 3 sources: Family, Friends, and Significant Other. The scale is comprised of 12 items, with 4 items for each subscale (28). Each item is scored on a 7-point Likert scale from 1 = very strongly disagree to 7 = very strongly agree. The MSPSS was initially validated in western, high-income countries but has since been validated in a number of non-western settings and LMICs with good reliability ranging from 0.86 to 0.90 (29, 30). In this study, MSPSS will be used to measure both adults living with cancer and family caregivers’ perception of the adequacy of the social support.
Spiritual need – The Spiritual Needs Assessment for Patients (SNAP) comprises 23 items in three domains: psychosocial (5 items), spiritual (13 items), and religious (5 items) (31). Each question is scored on a 4-point Likert scale ranging from 1 = very much to 4 = not at all. The total score can vary from 23–92, and higher values reflect more spiritual needs (32). Good reliability ranging from 0.74 - 0.95 has been reported (31).
A modified version of the SNAP will be used to measure the spiritual needs of the family caregiver. Three items will be modified (“getting in touch with other patients with similar illnesses” to “getting in touch with other family caregivers”, “finding meaning in your experience of illness” to “finding meaning in your experience of caregiving”, and “making decisions about your medical treatment that are in keeping with your spiritual or religious beliefs” to “making decisions about your loved one’s medical treatment that are in keeping with their spiritual or religious beliefs”) to reflect the family caregivers needs.
Information needs – The ten-item Information subscale of the Comprehensive Needs Assessment Tool for Cancer (CNAT) will be used to measure adults with cancer information needs (33). The eight-item Information subscale of the Comprehensive Needs Assessment Tool for Cancer- Caregivers (CNAT-C) (34) will measure family caregivers’ information needs. Items are scored on a 4-point Likert scale ranging from 0 = no need to 3 = high need. The CNAT and CNAT-C have Cronbach’s alpha internal consistency reliability ranging from of 0.79 - 0.97 (33, 34).
Cancer health literacy – Cancer health literacy (CHLT-6) (35) is a cancer-specific health literacy tool which differentiates between patients with adequate and limited cancer health literacy with a high degree of precision. Responses to the six items are scored as correct (1) or incorrect (0) and summed. Participants are considered to either have adequate cancer health literacy (total score 4 to 6) or limited cancer literacy (total score less than 4) (36). The CHLT-6 has a Cronbach’s alpha internal consistency reliability of 0.96 - 0.99 (35). It has been tested and used in Nigeria with good reliability of 0.74 (20). In this study, CHLT-6 will be used to measure both adults living with cancer and family caregivers’ health literacy.
Dependent variable
Quality of life – The Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) (version 4) combines the 27-item FACT-G and the 12-item FACIT-Sp (37, 38). FACIT-Sp will be used to assess the QoL of participants and a modified version will be administered to family caregivers. Items three, five, eleven, twelve, sixteen, seventeen, nineteen, twenty, twenty-four, thirty-eight, and thirty-nine were rephrased for family caregivers.
The survey consists of 39 items with five domains, assessing physical well-being (seven items), social/family well-being (seven items), emotional well-being (six items), functional well-being (seven items), and spiritual well-being (twelve items). Items are rated on a Likert-scale from 0 (not at all) to 4 (very much) (39). Higher scores indicate a more favourable perception of QoL (40). It has good internal consistency reliability ranging from 0.72 - 0.85 (41).
Data management and privacy procedures
All data will be password protected. All identifying information of participants will be coded and de-identified. Signed informed consent forms and returned coded/anonymised surveys will be stored in a secured project file, and access will be restricted to research team members, who will all sign a privacy statement. Data will be entered into the Statistical Package for the Social Sciences (SPSS) version 27 (42) database by a researcher not involved with the intervention and blind to participants' allocation. Data integrity will be assured by random consistency checks/re-entry of data. Archived electronic data will be kept for a maximum of seven years. Collected data will be processed anonymously in publications and reports, preventing identification of individual participants.
Approach to analysis
Data will be entered, cleaned, and analysed using SPSS. All statistical analyses will be performed based on intention-to-treat.
Descriptive statistics – Continuous demographic and clinical variables will be summarised by means and standard deviations, while categorical data will be described using frequencies and percentages and 95% confidence intervals. Normality assumptions of continuous outcome variables will be evaluated.
Inferential statistics – Parametric or non-parametric inferential statistical tests will be performed to assess for differences between adults with cancer and family caregivers' demographic/medical variables (e.g., age, gender, economic status, cancer type, and dyadic relationship) in intervention and control groups at baseline. If differences are detected, these variables will be controlled in subsequent analyses. To assess intervention efficacy, repeated measures Multivariate Analysis of Variance (MANOVA) will be used to analyse changes in study variables from time 1 to 2, with time and role (patient and caregiver) as within-subject variables to control for the correlated nature of the data.
Validity and reliability
Research assistant blinded to participant allocation and not involved in group facilitation will be responsible for collection of data. All instruments have been published and found to be reliable. The survey will be piloted with a Nigerian sample of five adults with cancer and five family caregivers. Group facilitators will have expertise in cancer care and group processes.
Steps would be taken to ensure intervention fidelity, such as ensuring that each participant received the same dose, and that the intervention period was set for a fixed number of groups. A programme manual was designed which contains precise detail of the content of each session. A programme manual will be developed that provides specific information about the content of each session.
Facilitators will undertake five days of training on the study aims, procedures, surveys, content of four sessions, group processes, use of registration forms, and data collection, during which they will become acquainted with the programme and their position within it. The importance of rigour will also be stressed. A digital version of the intervention protocol and facilitator guide will be made available to facilitators as part of their orientation and training for the study. The facilitators will be asked to fill out an intervention diary for each session in order to document any deviations from the programme. All analyses will be performed based on intention to treat.
Ethical considerations
The Declaration of Helsinki's ethical research principles will guide the study (43). The Ethics Committee of Ahmadu Bello University Teaching Hospital (ABUTH) Zaria, Nigeria (ABUTHZ/HREC/ W38/2020) and the Human Research Ethics Committee of Griffith University, Queensland, Australia (GU Ref No 2020/554) approved this study in May and July 2020, respectively. Written consent will be obtained from the participants.
Participation will be voluntary without coercion, manipulation, or undue influence. Participants will be duly informed that their consent is fluid and that they are free to withdraw at any point during the study process. The principle of justice and fairness will be adhered to by ensuring that all potential participants are treated equally without favour to individual on the grounds of religion, gender, age, or cadre.
Dissemination policy
After the study is completed, the findings will be disseminated across a variety of media, including open-access peer-reviewed journals and national and international conferences. The demonstrated efficacy would improve the intervention's implementation in clinical practice and communities in low and middle-income countries. Furthermore, the findings will inform a larger longitudinal RCT study.